MAUDE Adverse Event Report: MEDTRONIC PACEMAKER LEAD ADAPTER; PACEMAKER LEAD ADAPTOR

Model Number 2872

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This adapter was implanted on (b)(6) 2002 and remains implanted at the time.A call was placed to technical services on 10/27/2016 stating that this adapter involved in off label use.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: PACEMAKER LEAD ADAPTER
• Type of Device: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17531103
• MDR Text Key: 321419271
• Report Number: MW5138019
• Device Sequence Number: 1
• Product Code: DTD
• 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

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 2872
• Patient Sequence Number: 1