MAUDE Adverse Event Report: MEDTRONIC CAPSURE Z; PERMANENT PACEMAKER ELECTRODE

Model Number 5554

Device Problem Connection Problem (2900)

Patient Problem Pain (1994)

Event Date 06/29/2011

Event Type  malfunction  

Event Description

It was reported by the patient that he was told on (b)(6)2011 that his leads were connected incorrectly.He reported having a stinging pain from his throat to his left shoulder.No other information is known.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CAPSURE Z
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17517090
• MDR Text Key: 321279859
• Report Number: MW5124039
• 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: 09/01/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5554
• Patient Sequence Number: 1