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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 5392
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action. The device is no longer included as part of the field action. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the external pulse generator was not working properly. It was further reported that there was no additional in formation available at this time. The generator has been returned for service. There was no patient involvement.

 
Manufacturer Narrative

Analysis summary: analysis confirmed the customer comment that the device was not working correctly, the patient connector was broken and the device failed its incoming testing. The microprocessing unit was repositioned and calibrated however it failed and the main board was swapped out to resolve the issues. The main board, patient connectors and battery were replaced. The device passed its final testing. 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 Key7473469
MDR Text Key106962550
Report Number3004593495-2018-00451
Device Sequence Number1
Product Code DTE
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK150246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5392
Device Catalogue Number5392
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/25/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/30/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-1356-2015

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