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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS CYBERONICS VAGUS NERVE STIMULATOR

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CYBERONICS CYBERONICS VAGUS NERVE STIMULATOR Back to Search Results
Event Date 01/01/2009
Event Type  No Answer Provided  
Event Description

Rptr began to have increased neck and shoulder pain and increased seizures. The dr said it was arthritis and sent her to a pain specialist. It could be seen migrating, the device had disconnected. Decreased the voltage. Rptr finally had it removed 6 mos after her initial complaint. She was placed on additional anticonvulsants keppra and vimpat. She was already on dilantin and gabapentin. Rptr has developed anorexia and is losing weight. She is now (b)(6). She also is having trouble walking and has developed tremors. She feels it is from the medication and expresses concern that it has taken her physician so long to take drug levels when she has been wanting them done. Now he wants to take a battery of lab tests.

 
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Brand NameCYBERONICS
Type of DeviceVAGUS NERVE STIMULATOR
Manufacturer (Section D)
CYBERONICS
MDR Report Key2666397
Report NumberMW5026251
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/24/2012 Patient Sequence Number: 1
Treatment
GABAPENTIN 600 MG QAM AND 600 MG AT HS
VIMPAT 100 MG PO BID
DILANTIN 200 MG QAM AND 100 AT HS
KEPPRA EXTENDED RELEASE 750 MG QAM AND 100 MG QHS
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