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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION WIRE 6500F TEMP HEARTWIRE HEART-VALVE, MECHANICAL Back to Search Results
Model Number 6500F
Device Problems Pacing Problem; Material Split, Cut or Torn
Event Date 09/06/2018
Event Type  Injury  
Manufacturer Narrative

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 an unknown duration post implant of this temporary pacing lead, the lead was providing "inappropriate" stimulation resulting in "twisting of the peaks". The patient required heart massage and the lead was replaced. The biomedical department tested the generator and confirmed it was functioning as expected. No additional adverse patient effects were reported.

 
Manufacturer Narrative

Multiple attempts to obtain the implant and explant date of the lead were unsuccessful. The connection between the external generator (confirmed functioning as expected by the hospital biomedical department), and extension cable (when used) including the potential degradation and/or additional connection, or lead dislodgement combined with the medical condition and anatomy of the patient, may be foreseen as a potential root cause for the clinical observation. If information is provided in the future, a supplemental report will be issued.

 
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Brand NameWIRE 6500F TEMP HEARTWIRE
Type of DeviceHEART-VALVE, MECHANICAL
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view , MN 55112
7635055378
MDR Report Key8095252
Report Number2025587-2018-03158
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6500F
Device Catalogue Number6500F
Device LOT NumberDAB166306F
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/11/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/03/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/21/2018 Patient Sequence Number: 1
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