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

Model Number 1688TC

Device Problem High Capture Threshold (3266)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/08/2018

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2012.A product experience report was received on 06/07/2018 stating that this lead was capped on (b)(6) 2018 due to high pacing thresholds.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6).No other information is available.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: 17536417
• MDR Text Key: 321175455
• Report Number: MW5143305
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1688TC
• Patient Sequence Number: 1