MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION TEMPORARY PACING WIRE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6495F

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the initial implant of this temporary pacing lead, the lead was inserted into the patients chest wall, and one of the electrodes broke off of the lead and remained inside the patient.No additional adverse patient effects were reported. .

• Brand Name: TEMPORARY PACING WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12187622
• MDR Text Key: 262159779
• Report Number: 9611350-2021-00003
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00643169310100
• UDI-Public: 00643169310100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: 6495F
• Device Catalogue Number: 6495F
• Device Lot Number: CAA708207F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• Date Device Manufactured: 01/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1