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

Model Number 1688TC

Device Problem Expulsion (2933)

Patient Problems Pocket Erosion (2013); Foreign Body In Patient (2687)

Event Date 05/16/2016

Event Type  Injury  

Event Description

This rv lead was implanted on (b)(6) 2012 and was capped on (b)(6) 2016.A call was placed to technical services on (b)(6) 2018 stating that this lead was part of a system revision due to impending erosion on the lower left corner of the pocket.The physician was dr.(b)(6) at (b)(6) center 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: 17536732
• MDR Text Key: 321107086
• Report Number: MW5143616
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1688TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1