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

Model Number	6495F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12187622
• Report Number: 9611350-2021-00003
• Device Sequence Number: 3509084
• Product Code: LDF
• UDI-Device Identifier: 00643169310100
• UDI-Public: 00643169310100
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1