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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 Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 09/10/2015
Event Type  malfunction  
Manufacturer Narrative
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis confirmed that the output connector assembly was broken.It was also noted that the main printed circuit board was out of electrical specification.(b)(4).
 
Event Description
It was reported that the atrial and ventricular connectors of the external pulse generator were broken.The epg was returned for repair.There was no patient involvement.
 
Manufacturer Narrative
Further analysis was performed on the main board.Visual inspection revealed no anomalies.Bench analysis found that all tests passed.The error log was reviewed, there were no failures in the log.Conclusion: the main board failure could not be verified.
 
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Type of Device
PULSE-GENERATOR, PACEMAKER, EXTERNAL
Manufacturer (Section D)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY  11900
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5272206
MDR Text Key33067325
Report Number3004593495-2015-00316
Device Sequence Number1
Product Code DTE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2015
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 Manufacturer09/16/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
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
Patient Sequence Number1
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