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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK FIBROMYALGIA (UNAPPROVED)

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CYBERONICS, INC. PULSE GEN MODEL UNK FIBROMYALGIA (UNAPPROVED) Back to Search Results
Event Date 11/01/2006
Event Type  Injury  
Event Description

Follow up was performed with the authors of the article. It was indicated that no other information, besides what was available previously in the paper, would be available for disclosure. Per the reporter, information was previously provided to the manufacturer on issues which the authors deemed to be significant; however this cannot be confirmed as patient information was not provided.

 
Event Description

An article titled "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial" was received and reviewed on 10/03/2011. During the review of the article, it was reported that 2 study participants experienced worsening depression, reportedly due to the device and stimulation. This mdr was submitted to report the worsening depression of the first participant. Attempts for add'l pt and event info have been unsuccessful to date.

 
Manufacturer Narrative

Citation: lange, gudrun, malvin n. Janal, allen maniker, jennifer fitzgibbons, malusha fobler, dane cook, and benjamin h. Natelson, "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial". Pain medicine 2011; 12: 1406-1413.

 
Search Alerts/Recalls

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Brand NamePULSE GEN MODEL UNK
Type of DeviceFIBROMYALGIA (UNAPPROVED)
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 7705 8
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2324439
Report Number1644487-2011-02628
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/11/2012
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: 11/01/2011 Patient Sequence Number: 1
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