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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ELECTRODE, PACEMAKER, TEMPORARY

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MEDTRONIC, INC. ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 5833SL
Device Problems No Device Output ; Device Sensing Problem; Inadequate User Interface; Material Integrity Problem
Event Date 05/16/2018
Event Type  Injury  
Manufacturer Narrative

Analysis summary: analysis confirmed the customer comment of a seemingly malfunctioning cable, its negative continuity tests measured "open". If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that heart rhythm tracings (intercardiac) were unable to be obtained when the cable was in use and that the cable was unable to pace. The cable was returned to service. No patient complications have been reported as a result of this event.

 
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Brand NameNA
Type of DeviceELECTRODE, PACEMAKER, TEMPORARY
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
anne schilling
8200 coral sea st ne
mounds view , MN 55112
7635052036
MDR Report Key7605750
Report Number2182208-2018-01127
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5833SL
Device Catalogue Number5833SL
Device LOT Number664870001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/21/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/15/2018 Patient Sequence Number: 1
Treatment
383069 LEAD,
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