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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 01/26/2015
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery on (b)(6) 2015 due to an increase in seizures, the vns patient¿s replacement generator was tested with the existing lead which showed normal device function and battery status. After the patient was closed, the device was tested again and showed an end of service condition. The patient was reopened and another generator was used for the procedure. Follow-up revealed that electrocautery was used for the subcutaneous tissue during the procedure while the generator was inside the generator pocket. There was no indication that electrocautery had contacted or damaged the generator upon removal. Gloves were worn throughout the surgery to prevent potential static discharge to the generator. The suspect generator has been returned to the manufacturer where analysis is currently underway. The increase in seizures event was reported in manufacturer report # 1644487-2014-03183.

 
Manufacturer Narrative

 
Event Description

Analysis of the returned generator was completed. Review of the downloaded data indicated that the pulse disabled byte was set to a value that represents a vbat

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4532198
Report Number1644487-2015-03921
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/26/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2016
Device MODEL Number105
Device LOT Number4024
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/09/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/04/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/10/2014
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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