MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION WIRE 6500F TEMP HEARTWIRE; HEART-VALVE, MECHANICAL

Model Number	6500F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that a non-medtronic valve was implanted using this temporary pacing lead.The lead was removed following the surgery.The patient developed an aspergillus infection sometime after the surgery and had the non-medtronic valve replaced 5 days later.There are no specific allegations against the lead, however the health care professional (hcp) is reporting all the products used during that surgery.The hcp stated patient is doing well.

• Brand Name: WIRE 6500F TEMP HEARTWIRE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6826763
• Report Number: 2025587-2017-01491
• Device Sequence Number: 13467702
• Product Code: LWQ
• UDI-Device Identifier: 20643169310111
• UDI-Public: 20643169310111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 09/16/2018
• Device Model Number: 6500F
• Device Catalogue Number: 6500F
• Device Lot Number: DAA052307F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR