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

Model Number 1688TC

Device Problems Signal Artifact/Noise (1036); Nonstandard Device (1420); Low impedance (2285)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2012 and remains implanted at this time.A call was placed to technical services on 10/17/2016 reportedly stated impedance less than 200 ohms on the rv pace sense.Occasional rv noise but cannot reproduced in the clinic.The physician was dr.(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: 17531001
• MDR Text Key: 321408446
• Report Number: MW5137917
• 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

• 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