Devices

Device Recall Sigma Pacemaker

  • 모델명 / 제조번호(시리얼번호)
    Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SVDD303: serial no. PJD183400H - PJD183447H, PJD186130H - PJD186199H, PJD188418H - PJD188519H, PJD430299H - PJD430332H, PJD441378H - PJD441396H, PJD442436H - PJD442448H, PJD445371H - PJD448139H, PJD675113S - PJD675193S, PJD675694S - PJD676809S, PJD677182S - PJD677945S, PJD678157S - PJD686906S, PJD730001S - PJD744349S.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
  • 제품 설명
    Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment
  • 1 Event

제조사

Medtronic Inc. Cardiac Rhythm Managment
  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Fridley MN 55432
  • Source
    USFDA

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Device Recall Sigma Pacemaker
  • 모델명 / 제조번호(시리얼번호)
    Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com. Model SD203: serial no. PJD182918H - PJD191025H, PJD432660H - PJD449026H, PJD674196S - PJD690881S, PJD731443S - PJD743447S. Model SD303: serial no. PJD183969H - PJD186285H, PJD187584H - PJD187735H, PJD190274H, PJD190305H, PJD190308H, PJD195395H, PJD195444H, PJD441326 - PJD448026H, PJD674200S - PJD681640S, PJD691135S, PJD691231S, PJD729895S - PJD742209S.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
  • 제품 설명
    Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment
Device Recall Sigma Pacemaker
  • 모델명 / 제조번호(시리얼번호)
    Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SDR203: serial no. PJD183978h - PJD184012h, PJD186200H - PJD186279H, PJD187571H - PJD187669H, PJD193734H, PJD195394H - PJD195470H, PJD442170H, PJD445718H - PJD452929H, PJD674175S - PJD680868S, PJD685590S, PJD689228S, PJD691226S, PJD731742S - PJD739835S. Model SDR 303: serial no. PJD182452H - PJD199059H, PJD205280H, PJD440288H - PJD451956H, PJD674216S - PJD691410S, PJD730124S - PJD746998S. Model SDR 306: serial no. JE120662H - PJE120706H, PJE620733S - PJE621387S.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
  • 제품 설명
    Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment
Device Recall Sigma Pacemaker
  • 모델명 / 제조번호(시리얼번호)
    Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SS103: serial no. PJG160592H - PJG161247H, PJG162149H - PJG162607H, PJG163245H - PJG163805H, PJG165759H - PJG168541H, PJG170637H - PJG170921H, PJG428851H - PJG431485H, PJG677154S - PJG748119S, PJG748671S - PJG748710S, PJG748732S - PJG750863S, PJG751336S - PJG751944S, PJG752070S - PJG754744S, PJG231054M - PJG233721M, PJG748407C - PJG748670C, PJG748711C - PJG748722C. Model SS106: serial no. PJH117098H - PJH118839H, PJH624138S - PJH624610S, PJH626910S - PJH626967S. Model SS203: serial no. PJG165866H, PJG170641H - PJG170782H, PJG428850H - PJG431464H, PJG676637S - PJG681858S, PJG682490S, PJG683196S, PJG684296S - PJG689861S, PJG695412S, PJG747908S - PJG754745S, PJG231551M - PJG234346M. Model SS303: serial no. PJG162131H - PJG16371H, PJG427797H - PJG431510H, PJG676969S - PJG691865, PJG740396S - PJG757886S.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
  • 제품 설명
    Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment
Device Recall Sigma Pacemaker
  • 모델명 / 제조번호(시리얼번호)
    Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SSR203: serial no. PJG159204H - PJG178395H, PJG462302H - PJG434280H, PJG740166S - PJG766757S, PJG675988S - PJG694391S. Model SSR303: serial no. PJG159103H, - PJG178395H, PJG426302H - PJG434280H, PJG740166S - PJG766757S, PJG675988S - PJG694391S. Model SSR306: serial no. PJH116644H - PJH118708H, PJH624113S - PJH627050S.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
  • 제품 설명
    Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker, models SSR203, SSR303, SSR306
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment
Device Recall Sigma Pacemaker
  • 모델명 / 제조번호(시리얼번호)
    Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SVVI103: serial no.PJG159902H - PJG176701H, PJG432779H - PJG432895H, PJG230582M - PJG236398M, PJG677442S - PJG696014S, PJG748310S - PJG755468S, PJG747654C - PJG755171C.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
  • 제품 설명
    Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment