MAUDE Adverse Event Report: MEDTRONIC PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 4194

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported to technical services on 1 /12/11 that this iv lead could possibly be dislodged.It is showing loss of capture.Further testing will be done.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): MEDTRONIC
• MDR Report Key: 17528965
• MDR Text Key: 321311769
• Report Number: MW5135894
• 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: 02/03/2011

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: 4194
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1