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

Model Number 3207-6

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Shock from Patient Lead(s) (3162)

Event Type  malfunction  

Event Description

This device was implanted on (b)(6) 2008 and remains implanted up to this date.A call to technical services placed on (b)(6) 2013 states that patient complained of extracardiac stimulation.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6).No other information is available.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: 17531815
• MDR Text Key: 321409841
• Report Number: MW5138726
• 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: 06/17/2013

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: 3207-6
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1