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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 03/01/2010
Event Type  Malfunction  
Event Description

Additional information was received indicating that the increased seizures were believed to be related to the device nearing end of service. The patient has since been referred for a prophylactic replacement. The increase was back to the patient's pre-vns baseline frequency and all of the patient's seizure types have increased. There were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase/new seizure type. Diagnostics were said to be normal, however specific results were not provided. No additional information was received. Revision is likely but has not occurred to date.

 
Event Description

It was reported through clinic notes dated (b)(6) 2011, received on (b)(6) 2012, that the patient had an increase in seizures after a prolonged remission. It was reported that the patient had 3 seizures in one week. The seizures were described as generalized stiffening while remaining conscious. The patient had not reported these seizure types previously and no medication changes or triggering factors were identified. It was also indicated that an association between the new seizure type and psychogenic nonepileptic seizures cannot be ruled out. Attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 Key2451482
Report Number1644487-2012-00385
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/14/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2007
Device MODEL Number102
Device LOT Number014865
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/11/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/12/2006
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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