MAUDE Adverse Event Report: UNKNOWN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Patient Problem Asystole (4442)

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited high out of range pacing impedance measurements on this right ventricular (rv) lead, which led the crtp to trigger a lead safety switch (lss).It was noted that this rv lead also exhibited myopotential oversensing.The health care professional (hcp) called technical services (ts) for further review of the stored data.Upon, review, technical services (ts) noted asystole due to pacing inhibition from the myopotential oversensing.Ts recommended the hep to schedule the patient for a in person clinic visit to further evaluate the lead.No additional adverse patient effects were reported.At this time, this product remains in service.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).Reference report #mw5152415.

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18855414
• MDR Text Key: 337226425
• Report Number: MW5152416
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Patient Sequence Number: 1