MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number V173

Device Problems Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2021

Event Type  malfunction  

Event Description

6 months battery life remaining, the device went into a safety mode; whereby it reprogrammed to vvi at 72bpm, with unipolar sensing and pacing.There is no clear mechanisms as to why this transpired and the device is no longer programmable.In the setting of ventricular unipolar sensing, there was oversensing and resulting pacing inhibition.Need for urgent device replacement.

• Brand Name: INVIVE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11731489
• MDR Text Key: 247556194
• Report Number: 11731489
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31390 DA
• Patient Weight: 84