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

Model Number 1688TC

Device Problems Improper or Incorrect Procedure or Method (2017); Impedance Problem (2950); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2013

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2012 and remains implanted at this time.A call to technical services placed on 10/24/2013 states about lead safety switch.It occurred on (b)(6) 2013, impedance changed from 400-500 ohm range to less than 200 ohms.Patient is going for a chest x-ray and physician will schedule revision.The physician was dr.(b)(6) at (b)(6) in (b)(6).No other information is provided.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: 17531117
• MDR Text Key: 321422394
• Report Number: MW5138032
• 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

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