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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK GENERATOR

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CYBERONICS PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 01/01/2009
Event Type  Malfunction  
Event Description

Voluntary report # (b)(4) was received indicating that the patient began experiencing increased neck and shoulder pain as well as increased seizures. The report date of the voluntary report was indicated as (b)(6) 2012. The physician reportedly indicated that they believed this was arthritis and referred the patient to a pain specialist. The device could reportedly be seen migrating and had "disconnected". The report indicated that the physician "decreased the voltage". The vns was reportedly removed 6 months following the initial complaint however it was not indicated if this refers to the vns lead, generator, or both. It was noted keppra and vimpat were added to the patient's treatment plan and she was already taking dilantin and gabapentin. The patient reportedly developed anorexia and is losing weight. There is a comment indicating "she is now (b)(6)" however it is not indicated what this is referring to. It was also noted that the patient is having trouble walking and has developed tremors however the patient reportedly feels these are related to the medication but it is indicated that drug levels have not been taken in some time despite requests from the patient.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2721027
Report Number1644487-2012-02175
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/02/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/02/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/30/2012 Patient Sequence Number: 1
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