MAUDE Adverse Event Report: MEDTRONIC UNKNOWN; PERMANENT PACEMAKER ELECTRODE

Model Number 4968

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Technical services received a call on 08/24/2011 from sales rep.Lead connection issue.No other information was available at this time.No physician or hospital known.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17527499
• MDR Text Key: 321406951
• Report Number: MW5134431
• Device Sequence Number: 1
• Product Code: DTB
• 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: 10/06/2011

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: 4968
• Patient Sequence Number: 1