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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 05/22/2019
Event Type  Malfunction  
Event Description

Patient underwent generator replacement surgery due to battery depletion. It was further reported that the generator was unable to be interrogated prior to the generator replacement due to battery depletion. The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process. Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths. The explanted generator was received and product analysis was completed. The product analysis lab confirmed that the generator was at end of service condition. A visual assessment on the pcba showed contaminates on the trimmed edge of the pcba. The battery was removed. 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 contribute to the reported failure to program event due to eos (end of service). There were no other performance of any other type of adverse events found with the pulse generator.

 
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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 Key8833391
Report Number1644487-2019-01464
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/26/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2019
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 Number203469
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/06/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/09/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/11/2015
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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