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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 09/03/2015
Event Type  Malfunction  
Event Description

It was reported that the patient's generator was replaced due to low battery. The generator was returned and underwent product analysis where residual material, contaminates, on the printed circuit board assembly (pcba) resulted in increased current consumption for standby and pulse modes of operation. Due to the presence of the contaminates, the generator failed several electrical tests due to out of specification supply currents. The observed conductive debris suggests probable current leakage paths and premature depletion. After the contaminants were removed the generator passed the same electrical tests. The contamination that was observed on the trimmed edge of the pcba suggest probable electrical and resistive paths were established between the copper edges on the pcba, which contributed to the supple current conditions. The device history record of the generator were reviewed and indicated that the generator passed functional specifications prior to distribution, and it was confirmed that the device was laser-routed during the manufacturing process. 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8283594
Report Number1644487-2019-00155
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 01/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/29/2017
Device MODEL Number106
Device LOT Number203500
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/04/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/03/2015
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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