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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 07/22/2014
Event Type  Injury  
Event Description

It was reported that the recently implanted vns patient underwent surgery on (b)(6) 2014 to explant his generator and lead. The patient had been scratching at his cervical wound site which subsequently led to extrusion of the electrode. It was noted that the patient had a history of combativeness, aggressiveness, and self-mutilating behavior. The patient went to the er where approximately 6cm of the patient¿s lead was found to be visibly extruding from the approximate 6mm opening of the patient¿s wound. There was no purulence but the patient was sent for surgery due to risk of infection. During explant, granulation tissue was found at the area of dehiscence and a significant amount of scarring was noted within the patient¿s neck. The extruding portion of the patient¿s lead was cut and discarded. Samples were taken for cultures and the patient¿s wound was cleaned and irrigated. The patient has not been re-implanted to date.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key4131361
Report Number1644487-2014-02524
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/08/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2015
Device MODEL Number105
Device LOT Number202828
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/08/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/12/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/01/2014 Patient Sequence Number: 1
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