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

Model Number 1488TC

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Date 11/21/2013

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2000 and remains implanted at this time.A call to technical services on 11/17/2013 states that patient is pacer dependent with intermittent non-capture rv lead.The physician was dr.(b)(6) at (b)(6) in (b)(6).Plan was to check the device and set outputs appropriately.No other information is available.Additional information placed to technical services on 11/22/2013 states that this rv lead was capped and replaced on (b)(6) 2013 due to increasing thresholds.The threshold pre changeout was 3v @ 0.5 ms and 2.5v @ 1.0 ms.The physician was dr.(b)(6) at (b)(6) in (b)(6).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: 17523985
• MDR Text Key: 321404561
• Report Number: MW5130933
• 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: 12/17/2013

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