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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD PULSE-GENERATOR, PACEMAKER, EXTERNAL

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PLEXUS MANUFACTURING SDN. BHD 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 Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that during normal use, the external pulse generator (epg) would reset to nominal settings. The epg is expected to be returned, but its current status is unknown. There was no patient involvement.

 
Manufacturer Narrative

Product analysis: manufacturer's analysis confirmed the customer comment that the external pulse generator (epg) would reset to nominal values. It was indicated that a display subassembly was out of specification and a software update was required, the epg was repaired and returned to service. This device was reported as included in the field action noted and returned product investigation found the device performed as described in the field action. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The epg was returned for service.

 
Manufacturer Narrative

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)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY 11900
Manufacturer (Section G)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY 11900
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7415119
MDR Text Key105264050
Report Number3004593495-2018-00204
Device Sequence Number1
Product Code DTE
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK162054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
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 Manufacturer06/04/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-2317-2018

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