MAUDE Adverse Event Report: ST. JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1882TC

Device Problems Energy Output Problem (1431); Over-Sensing (1438)

Patient Problem Tachycardia (2095)

Event Type  Injury  

Event Description

It was reported, that the implantable cardioverter defibrillator (icd) system oversensed far-field ventricular signals in the atrial channel.Leading to inappropriate atrial tachy response (atr) episodes.Boston scientific technical services (ts) reviewed the recorded episodes, and indicated the majority of the far-field signals are not falling into the programmed blanking periods.Additionally, the amplitude of the right atrial (ra) lead exhibited a significative decrease since implant.The ra lead is a not a boston scientific device.Ts recommended adjusting the blanking periods.Testing the atrial lead integrity in clinic by isometric testing and comparing the current position of the lead versus the implant position.The field representative communicated the suggestions to the physician.At this time, no adverse patient effects have been reported.And the system remains in service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17535198
• MDR Text Key: 321151083
• Report Number: MW5142097
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1882TC
• Device Lot Number: CWG037967
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1