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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 01/01/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2014 note that the patient's seizures are fifteen times a month and last two to three minutes. It was noted that the patient experienced an increase in seizures in (b)(6) 2013 with two seizures for over a week. The physician increased the device output current to 2ma and the patient became seizure free again. The notes indicate that the patient has experienced more frequent seizures that have changed in character. It was noted that there have been no recent medication changes. Clinic notes dated (b)(6) 2014 note that the patient's seizures are every other day and are shorter and less impairing. The assessment notes that vns placement and rufinamide have helped seizures, but she continues to have approximately 8 complex partial seizures per month. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

Additional clinic notes were received. The clinic notes report that shortly after the vns surgery (in (b)(6) 2013), the patient had a different seizure presentation. Patient stares and patient¿s head will often slump down. No arm movement was observed. These were happening once per day at various times, lasting about 3 min each time, and started shortly after her surgery. The clinic notes also report that from (b)(6) 2013, the vns current was at 1. 5ma and the patient had several auras but no seizures. Then the vns was increased to 1. 75ma on (b)(6) 2013 and the patient had 1-2 seizures per day from (b)(6) 2013 so the vns was decreased back to 1. 5 per the parent¿s requests. Additional information was received from the neurologist that there were no medication changes that could have caused or contributed to the new seizure type. Per the physician, the new seizure type is not likely related to vns therapy.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3790928
Report Number1644487-2014-01199
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/05/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2014
Device MODEL Number102
Device LOT Number202207
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/21/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/22/2012
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: 05/05/2014 Patient Sequence Number: 1
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