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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102R

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CYBERONICS INC PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 08/11/2011
Event Type  Malfunction  
Event Description

It was reported in a pt's clinic notes that the pt had been seen on (b)(6) 2011, his diagnostics were within normal limits. However, on (b)(6) 2011, the pt's mother stated that the pt's seizures had become more intense and were occurring with a greater tendency towards clusters in the middle of the month. It was not known if this was caused by the pt's menopausal rhythm. When the generator was attempted to be interrogated, communication was not possible. Multiple, known good wands were used without success. The physician concluded that he suspected the device was still functioning, but was not delivering the full stimulation based on these facts. An arrangement to replace the device was ordered. Attempts for further info have been unsuccessful.

 
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Brand NamePULSE GEN MODEL 102R
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key2271415
Report Number1644487-2011-02160
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/26/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/16/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date08/31/2009
Device MODEL Number102R
Device LOT Number200633
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/26/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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