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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 08/21/2011
Event Type  Injury  
Event Description

Analysis of the vns generator has been completed. No anomalies were noted and the generator performed per specifications.

 
Event Description

Reporter indicated the patient had prophylactic vns generator replacement surgery performed. The reporter attributes the increased seizures to the battery nearing end of service, even though the end of service indicator on the generator was "no". The seizures were increased to pre-vns baseline levels. The patient has multiple seizure types and all were increased but the exact seizure type was not specified. No other interventions were done for the seizure increase other than replacing the vns generator. The generator replacement was not done to preclude a serious injury. The explanted generator has been returned and is pending product analysis.

 
Event Description

Reporter indicated a vns patient began having increased seizures on (b)(6) 2011. Prophylactic replacement of the vns generator is planned, but no surgery date has been set. Attempts for further information are in progress.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2267515
Report Number1644487-2011-02295
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/02/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2006
Device MODEL Number102
Device LOT Number012081
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/28/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/01/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/23/2005
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: 09/28/2011 Patient Sequence Number: 1
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