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

Model Number 1888TC

Device Problems Failure to Capture (1081); Under-Sensing (1661); Device Sensing Problem (2917)

Patient Problem Chest Pain (1776)

Event Date 04/01/2011

Event Type  Injury  

Event Description

Boston scientific received information that a patient implanted with a st jude medical lead, exhibited undersensing, loss of capture (loc) and right ventricular (rv) threshold issues.The lead impedance measurements were stable, and there were no adverse patient effects reported other than the patient complaining of intermittent chest pain.The decision was made to reprogram the device.It should be noted the associated rv lead is a competitor product.Hospital: royal alexandra hospital canada event date (b)(6) 2011.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: 17525771
• MDR Text Key: 321106562
• Report Number: MW5132712
• 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: 05/04/2011

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: 1888TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1