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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PULSE-GENERATOR, PACEMAKER, EXTERNAL

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MEDTRONIC, INC. PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 53401
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/15/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that the external pulse generator (epg) was not working properly. The epg was returned for service. There was no patient involvement.

 
Manufacturer Narrative

Product analysis: manufacturer's analysis confirmed the customer comment that the external pulse generator (epg) was not working properly. It was indicated that the printed circuit board (pcb) was out of specification and that there were errors in the logs. The epg was repaired and returned to service. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

Product analysis: manufacturer's analysis was unable to confirm the customer comment that the external pulse generator (epg) was not working properly. The epg passed incoming testing. The epg was returned to service. If information is provided in the future, a supplemental report will be issued.

 
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Type of DevicePULSE-GENERATOR, PACEMAKER, EXTERNAL
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 Key7417398
MDR Text Key105313056
Report Number2182208-2018-00555
Device Sequence Number1
Product Code DTE
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK162054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number53401
Device Catalogue Number53401
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/20/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/04/2017
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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