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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 08/12/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that this patient was referred for a generator replacement due to near end of service (neos) = yes. The patient received a generator replacement and the explanted generator was returned for product analysis. The generator underwent product analysis and a the vns programming history database shows that the neos=yes was set on the day of explant. A visual assessment on the printed circuit board assembly (pcba) showed contaminates on the trimmed edge of the pcba. The battery was removed. The pcba was subjected to an electrical test and results show that the pcba failed several electrical tests. After the trimmed edge of the pcba was cleaned, an electrical test was performed and the generator passed all electrical tests. Based on the electrical test results, 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. Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for both standby and pulsing modes of operation, and may have been the contributing factor for the reported allegation of replacement due to battery depletion (neos = yes). The dhr of the generator was reviewed, and the device passed all functional specifications prior to release. It was also confirmed that this device was manufactured during the time that m106 generators were laser-routed. No other 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 Key8211956
Report Number1644487-2019-02403
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 01/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/05/2017
Device MODEL Number106
Device LOT Number203471
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 Received12/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/12/2015
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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