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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 Device Operates Differently Than Expected; Material Integrity Problem
Event Date 04/18/2018
Event Type  Malfunction  
Manufacturer Narrative

Product analysis: the complaint was confirmed; positive connection continuity tests on the cable measured open. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that device testing was unable to be performed using this cable. A different cable was able to be used with no issue. The cable was returned. 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 Key7516706
Report Number2182208-2018-00913
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5833SL
Device Catalogue Number5833SL
Device LOT Number663970001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/30/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/16/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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