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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 Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2018
Event Type  Injury  
Manufacturer Narrative

Event relates to medwatch report: mw5075151. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that while in use with a patient, the external pulse generator (epg) would not stay in manual settings as it would revert to default settings. The status of the epg is unknown. No patient complications have been reported as a result of this event.

 
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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 Key7460422
MDR Text Key106492065
Report Number3004593495-2018-00367
Device Sequence Number1
Product Code DTE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK162054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 04/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number53401
Device Catalogue Number53401
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2018
Was Device Evaluated By Manufacturer? No Answer Provided
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: 04/25/2018 Patient Sequence Number: 1
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