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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 06/27/2014
Event Type  Malfunction  
Event Description

It was reported that the recently implanted vns patient¿s device was interrogated during an office visit on (b)(6) 2014. The device showed a message stating ¿vbatt < eos threshold. ¿ the neurosurgeon stated that electrocautery was not used during the implant procedure. The patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator was returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the returned generator was completed. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The device showed a non-ifi condition. Other than the noted event, there were no performance or any other type of adverse condition found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 103
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 Key3963735
Report Number1644487-2014-01884
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2015
Device MODEL Number103
Device LOT Number3832
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/14/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/06/2014
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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