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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 09/26/2018
Event Type  Malfunction  
Event Description

It was reported that the patient was referred for vns generator replacement surgery. The patient underwent replacement surgery and the implant card received by the manufacturer indicated that the reason was due to battery depletion. The explanted generator was received by the manufacturer. Generator product analysis was completed. The end of service, or eos, allegation was not duplicated in the product analysis, or pa, lab. The battery measured 2. 976 v at the completion of the fet, indicating an intensified follow-up indicator, or ifi, = no condition. The device performed according to functional specifications. A visual assessment of the printed circuit board assembly, or pcba, revealed contaminates on the trimmed edge of the pcba. The data dump was reviewed and at the time of review, the battery voltage measured 2. 710 (ifi = yes). The diagaccumconsumed value was 74. 817%. High impedance was observed on the day after the implantation of the generator. No further high impedance were observed in the lead impedance history until after generator explantation. The high impedance was reported in mfg. Report #1644487-2019-00019. The data in the ¿diagvbat_min¿ memory locations show a value of 2. 674 volts approximately a week and a half post-explant. There were no performance or other adverse conditions found with the generator. Based on the data available through product analysis, it was unclear whether a premature end of life indicator was present at the time of the explant. A review of device history records revealed that the generator passed quality control inspection prior to distribution. No additional 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 Key8223607
Report Number1644487-2019-00021
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/08/2017
Device MODEL Number106
Device LOT Number4363
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/03/2015
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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