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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC ELECTRODE, PACEMAKER, TEMPORARY

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MEDTRONIC HEART VALVES DIVISION MEDTRONIC ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 6495F
Device Problems Over-Sensing; Pacing Inadequately
Event Date 11/01/2018
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 during use on a patient in complete heart block, this temporary pacing lead was not providing the expected therapy. The wire was removed and replaced with non-medtronic temporary pacing leads. The same pacing control box (external) was used with the replacement leads. No additional adverse patient effects were reported.

 
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Brand NameMEDTRONIC
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 Key8121883
Report Number9611350-2018-00004
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/25/2020
Device MODEL Number6495F
Device Catalogue Number6495F
Device LOT NumberCAB244206F
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 Received11/21/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/25/2018
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: 12/01/2018 Patient Sequence Number: 1
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