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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 09/03/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that a pt would have the device explanted due to psychosis. Good faith attempts to obtain additional info from the pt's physician have been unsuccessful to date. No programming or device diagnostic history is available in the in-house database. The pt's generator has been explanted and returned to the mfr and proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. There were no performance or any other type of adverse conditions found with the pulse generator. The pulse generator performed according to specifications.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section F)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
(281) 228 -7200
Device Event Key1551592
MDR Report Key1502162
Event Key1429582
Report Number1644487-2009-02249
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/09/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date07/28/2010
Device MODEL Number102
Device LOT Number200880
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/14/2009
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received09/09/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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