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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 Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 07/02/2015
Event Type  Malfunction  
Event Description

Product analysis of a product replaced prophylactically was completed. Evidence of premature battery depletion due to contaminants of the pcba from the laser-routing manufacturing process were identified. A visual assessment of the pcba showed contaminates on the trimmed edge of the pcba. The pcba failed several tests of the post-burn electrical tests. 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 an excessive supply current conditions. After the trimmed edge of the pcba was cleaned, the generator performed according to specifications with no further anomalies identified. Note that the internal data of the generator also showed evidence of premature depletion with the battery voltage being inconsistent with the % battery consumed. The manufacturer's device history records were reviewed and it was verified that the generator passed final quality and functional specifications prior to release. The generator was confirmed to have been laser-routed. No further relevant information has been received to date.

 
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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 Key8123346
Report Number1644487-2018-02187
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/16/2017
Device MODEL Number106
Device LOT Number4397
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/05/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/06/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/02/2015
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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