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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC.

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MEDTRONIC, INC. Back to Search Results
Model Number UNK-LEAD-PACING
Device Problems Failure to Capture; Over-Sensing; Pacing Problem
Event Date 06/08/2019
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the implantable pulse generator (ipg) exhibited pacing pauses longer then one beat, possibly due to oversensing or loss of capture. Consequently, the patient experienced syncope and was intubated to put in temporary lead. The ipg and the pacing lead remains in use. No further patient complications have been reported as a result of this event.

 
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Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view , MN 55112
7635055378
MDR Report Key8758754
Report Number2182208-2019-01200
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberUNK-LEAD-PACING
Device Catalogue NumberUNK-LEAD-PACING
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 Received06/08/2019
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: 07/03/2019 Patient Sequence Number: 1
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