MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 4193

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported to technical services on (b)(6) 2011 that this lead was abandoned sometime in 2005 and is now being removed as the md does not like where it is this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MEDTRONIC
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17520163
• MDR Text Key: 321044629
• Report Number: MW5127111
• Device Sequence Number: 1
• Product Code: LWP
• 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: 12/06/2011

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: 4193
• Patient Sequence Number: 1