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

Model Number 1488TC

Device Problem Intermittent Capture (1080)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2013

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2001 and was capped on (b)(6) 2013 due to no capture at sv at 1.0ms in bipolar.Threshold in unipolar is 1.4v at 1.0ms.The physician was dr.(b)(6) at (b)(6) hospital south in charlotte, nc.No additional 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: 17535764
• MDR Text Key: 321362943
• Report Number: MW5142658
• 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: 06/17/2013

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: 1488TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1