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

Model Number 1688T

Device Problems Over-Sensing (1438); No Pacing (3268)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2016

Event Type  malfunction  

Event Description

This lead was implanted on an unknown date and still remains implanted at this time.It was noted on (b)(6) 2016 that the lead exhibited standstill and has no pacing with at least 1 second of just p waves at a rate of 88.The lead also exhibited farfield oversensing which inhibit ventricular pacing for about 1.5 seconds.The physician was dr.(b)(6) at (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: 17537395
• MDR Text Key: 321417036
• Report Number: MW5144273
• 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: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1688T
• Patient Sequence Number: 1