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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
Device Problems Battery; Device Inoperable
Event Date 04/10/2009
Event Type  Malfunction  
Event Description

It was reported that a pt's seizures had worsened recently and that the physician indicated, the device was not working and would need to be replaced. The pt states that now seizures are occuring two to three times a day and now the seizure type has changed in that the pt will now black out and feel like time is passing by rapidly. A battery life calculation was performed using the limited data available in the in-house programming database and it was found that the pt's device is currently at end of service. Good faith attempts to obtain additional info from the pt's physicians have been unsuccessful to date.

 
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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 Key1468064
Report Number1644487-2009-01579
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/10/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/24/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2005
Device MODEL Number102
Device LOT Number9157
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/10/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2003
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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