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

Model Number 4023

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2012

Event Type  malfunction  

Event Description

Boston scientific received information stating: during a replacement of a pacemaker, 3 medtronic screwdrivers where used to try to free the leads from the device, all 3 screwdrivers broke without being able to free the set screws.Finally a torque device was used and the set screw could be released.It was the ring screw on rv connector that was the problem.There where no other problem with the replacement.(b)(6) (rn).Bor?hospital (b)(6) sweden.Lead implant date (b)(6) 1996.Event date (b)(6) 2012.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CAPSURE SP
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17521262
• MDR Text Key: 321361882
• Report Number: MW5128210
• 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: 12/21/2012

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: 4023
• Patient Sequence Number: 1