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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 01/20/2011
Event Type  Injury  
Event Description

It was reported by a neurologist via clinic notes that a vns pt had a variable seizure control on (b)(6) 2011. Pt also reported a new type of seizure episode where he could not move for a few seconds which occurred about once a week. The vns diagnostics were within normal limits on (b)(6) 2011. On (b)(6) 2011, the pt reported that this whole body "freezes" and he remains stiff for approx 30 seconds to one minute (exact duration is unk). These events occur primarily at night about twice per day. The physician does not know about the exact cause of pt's body freeze but believe that these episodes are either sensory or motor related. Pt has not tried the vns magnet during these events. During the examination on (b)(6) 2011, the physician could ot communication with pt's device and believed that the generator was at end of service. Mfr battery life calculation resulted in negative battery life indicating end of service. The pt will likely have a revision surgery. Attempts for additional info are in progress.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
suite 600
houston , TX 77058
2812287200
MDR Report Key2236541
Report Number1644487-2011-02020
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/05/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2009
Device MODEL Number102
Device LOT Number200670
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/05/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2007
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: 08/31/2011 Patient Sequence Number: 1
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