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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 08/11/2011
Event Type  Injury  
Event Description

It was reported that the pt's vns generator was scheduled to be replaced because it had migrated to the axilla. Diagnostics were within normal limits as per the physician. X-rays were taken to assess the condition of the vns lead however they will likely not be sent to the manufacturer for review. The pt was also noted as experiencing an increase in seizures that coincided with the generator moving beneath the armpit. The relationship of this increased seizure frequency to the pre-vns baseline frequency is unknown. Surgery to replace the pt's generator has occurred. It is believed that the migration is related to the previous surgeon not using a suture to secure the pt's generator properly. No trauma or manipulation was reported. Attempts for further info and return of the pt's explanted generator 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.
ste 600
houston , TX 77058
2812287200
MDR Report Key2256562
Report Number1644487-2011-02177
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/15/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2006
Device MODEL Number102
Device LOT Number010275
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/16/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2004
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: 09/15/2011 Patient Sequence Number: 1
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