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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION UNIPOLAR TEMPORARY MYOCARDIAL PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 6494
Device Problem Material Separation
Event Date 12/09/2019
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 upon removal of this temporary pacing lead, the fixation coil was left inside the body when the lead fractured at the end. No adverse patient effects were reported.  .

 
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Brand NameUNIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
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 Key9499677
Report Number2025587-2019-03837
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 12/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6494
Device Catalogue Number6494
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 Received12/09/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 12/19/2019 Patient Sequence Number: 1
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