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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 07/13/2015
Event Type  Malfunction  
Event Description

Product analysis was completed on a generator returned from a prophylactic battery replacement surgery, and found evidence of premature battery depletion. Upon opening the generator can, visual analysis identified contaminates on the trimmed edge of the pcba. The contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths that contributed to the supply current conditions, and the battery depleting prematurely. Product analysis confirmed that the battery status was ifi=yes condition due to the contaminates on the trimmed edge of the pcba. No further anomalies were identified. The manufacturer's device history records were reviewed. The generator passed final quality and functional specifications prior to release. Based on the date of the trim tab test the generator was subjected to the laser-routing. No additional, relevant information was 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 Key8429563
Report Number1644487-2019-00526
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 03/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/03/2017
Device MODEL Number106
Device LOT Number4407
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/19/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/21/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/13/2015
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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