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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 08/08/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient was having issues with pain and with device migration. Clinic notes were received indicating that the patient had severe fatigue and tremors over the last two months. She later reported having a strange tremor in her head that occurred several times per day. It was noted that patient¿s device had migrated from its original position and was located at the wall of the axilla. Chest and neck x-rays were ordered because the patient reported occasional shocking sensations to the left side of the neck. The patient was instructed to temporarily disable her device with the magnet to determine whether her symptoms would subside. An implant card was received indicating that the patient underwent generator and lead replacement surgery due painful stimulation, shocking sensations and lead discontinuity. The patient¿s lead reportedly fell off the patient¿s vagus nerve and caused high impedance. The explanted generator and lead have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key4103125
Report Number1644487-2014-02409
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/22/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2006
Device MODEL Number302-20
Device LOT Number010850
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/22/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/06/2004
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: 09/19/2014 Patient Sequence Number: 1
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