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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION WIRE 6500F TEMP HEARTWIRE ELECTRODE, PACEMAKER, TEMPORARY

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MEDTRONIC HEART VALVES DIVISION WIRE 6500F TEMP HEARTWIRE ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 6500F
Device Problems Pacing Problem; Failure to Sense
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 and "tracing", with no clinical signal identified from the lead. The biomedical department tested the generator and confirmed it was functioning as expected. The lead was replaced. No adverse patient effects were reported.

 
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Brand NameWIRE 6500F TEMP HEARTWIRE
Type of DeviceELECTRODE, PACEMAKER, TEMPORARY
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 Key8095098
Report Number2025587-2018-03157
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 11/21/2018
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 NumberDAB164306F
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/26/2018
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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