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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 302

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CYBERONICS LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 03/26/2015
Event Type  Injury  
Event Description

It was reported that the vns patient had presented a sharp pain in the left side of the neck and pulling sensation. The patient did not perceive the stimulation and she could not indicate whether the pain occurred with stimulation or not. The settings were programmed at 1. 5ma, 25hz, 130usec, 30secs on and 5mins off. The patient has dystonia and moves her neck quite a lot. X-rays were recommended but the patient did not wish to undergo any further surgical revision and preferred to have the generator disabled. Additional information was received indicating that the patient was implanted for depression. The pulse generator vns was disabled as the patient was experiencing severe discomfort. The patient wishes to undergo vns explant surgery because she believes that her cervical dystonia/torticollis is being worsened by vns. It was reported that the patient presented a severe pain episode caused by the lead, which seemed to be protruding more than it had done previously. It was reported that the patient also presented breathing difficulties, loss of some vision in one eye, severe pain in the middle of her back and abdominal pain which was relieved by the application of plasters. It was believed that these symptoms were related to the patient¿s depression. Surgical intervention for the explant of the vns system is expected but it has not occurred to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS
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 Key4804054
Report Number1644487-2015-04792
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 05/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number302-20
Device LOT Number201322
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received05/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/19/2010
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: 05/29/2015 Patient Sequence Number: 1
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