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

Model Number 1688TC

Device Problem Failure to Capture (1081)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A call to technical services was made on 10/15/2013 stating that patient was in emergency room wherein loss of capture was noted.Representative tested the device and confirmed loss of capture.Patient's intrinsic rate was in the 30's.The device was programmed 2.0v @.4 msec.Threshold was 2.3 v @.4 msec.Representative reprogrammed autocapture on which chose output of 2.8 v.There was no impedance changes or other signs of a lead issue.Patient will follow up with dr.(b)(6) at (b)(6) hospital.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: 17524794
• MDR Text Key: 321450653
• Report Number: MW5131738
• 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: 1688TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1