Device Recall Medtronic InSync II Marquis

  • 모델명 / 제조번호(시리얼번호)
    Model 7289 InSync II Marquis (serial numbers listed include all affected devices but may include some unaffected devices. Patients are recommended to check with their doctor for exact serial numbers affected.) S-Series: PRJ600001 - PRJ609639S and PRJ614813 - PRJ614815S
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    worldwide
  • 제품 설명
    Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.
  • Manufacturer
  • 1 Event

제조사

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