5348 Single-Chamber External Pulse Generator 의 안전성 경고

Safety alert

2014-05-05

2014-05-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140505a.html

Medical device safety alert: medtronic model 5348 single-chamber external pulse generator medical device manufacturer, medtronic inc., has issued a field safety notice concerning single-chamber external pulse generators (epgs). the affected model is 5348 and the affected serial numbers are within ranges of pep001001p to pep050019p and pep001001k to pep001714k. the manufacturer has identified a performance issue potentially affecting older model 5348 epgs manufactured between july 1995 and december 2007. this issue does not affect any other epg models or any medtronic implantable devices. through 16 april 2014, the manufacturer has determined 49 events (out of approximately 30,000 potentially affected 5348 epgs, or 0.16 percent), were related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm). the root cause of this issue is the development of high resistance on internal electrical connector contacts due to oxidation over time. due to the unpredictable nature of the oxidation process on multiple electrical contacts, this issue may result in one or more of the following observations: pacing rate outside of the intended setting, potentially including a sudden increase in pacing rate up to the maximum setting of 180 ppm. output amplitude or sensitivity outside of intended setting. pace, sense, or low battery led indicators not lighting during power on or reset functions. rapid atrial pacing (rap) display with intermittent functionality. intermittent functionality of the on/off and rap control button. the manufacturer recommends the following actions be taken when using a potentially affected model 5348 epg: monitor the epg function and patient’s heart rhythm continuously while the epg is in use to ensure it is operating properly and delivering appropriate therapy to the patient. if any malfunction is observed with a 5348 epg, ensure the patient’s condition is stabilized, discontinue use of the model 5348 device and contact the manufacturer. according to the manufacturer, they will no longer service or repair epgs that are more than five years old, including these potentially affected 5348 epgs; which is consistent with the five-year service life of the new model 5392 epg. the manufacturer will separately communicate additional details about this new epg service policy. the manufacturer advises customers to contact them for assistance with purchasing a replacement device if customers choose to replace their potentially affected 5348 epg. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 5 may 2014.