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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 08/26/2015
Event Type  Malfunction  
Event Description

The patient was replaced and the explanted generator was returned to the manufacturer. Product analysis was performed on the returned generator. Based on the results, the generator prematurely depleted. The pulse generator performed according to functional specifications. Based on the postburn electrical test, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions. The design history record was reviewed for the generator. The device passed all specifications prior to distribution. The time of the trim test tab indicated this generator underwent laser routing and is susceptible to premature depletion. No additional or relevant information was received.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8206707
Report Number1644487-2018-02388
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/31/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/14/2017
Device MODEL Number106
Device LOT Number203490
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/17/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/26/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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