MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION UNIPOLAR TEMPORARY ATRIAL PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6492

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

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 this temporary pacing lead wire was hard to remove and did not stay in place.No adverse patient effects or interventions were reported.

• Brand Name: UNIPOLAR TEMPORARY ATRIAL PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 103 route d anor; fourmies nord 59610 ; FR 59610
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 103 route d anor; fourmies nord 59610 ; FR 59610
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12530053
• MDR Text Key: 273309363
• Report Number: 9611350-2021-00005
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6492
• Device Catalogue Number: 6492
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2021
• 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