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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 04/12/2012
Event Type  Malfunction  
Event Description

A nurse reported on (b)(6) 2012, that a patient, who was implanted with vns on (b)(6) 2012, had an increase in seizures and new seizure type when the output current was increased from 0. 5ma to 0. 75ma. The patient's parents reported that they taped the magnet on the generator, and the seizures stopped. The nurse turned the output current back to 0. 5ma a few weeks prior. The plan was to try and titrate the output current up again. If the seizures got worse again, the nurse planned on lowering the current again and try it for another month. The patient's regular seizures were reportedly now back at pre-vns baseline level. The only difference in the patient's seizures was the new type of seizure. No causal or contributory or external factors preceded the onset of the events. Follow up with the nurse revealed that the device was programmed from 0. 75ma to 1. 0ma on (b)(6) 2012, and the caregiver reports the increased seizures occurred that evening, and the seizure semiology was reported to be known. It is believed that the patient has experienced complex partial and secondary generalized seizures since vns implant. However, it is unclear if both of these seizures types are new for the patient since implant. In addition, the date in which the new seizure type was first observed is unclear with the information provided. Attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

Additional information received indicated that the nurse may attribute the patient's increased seizures to the model 103 generator. As such, the type of reportable event is now considered to be a malfunction. (b)(4).

 
Event Description

It was reported that the nurse believed that there may be an issue with the model 103 generators because she has another vns patient who has experienced an increase in seizures when programming settings were changed, as reported in manufacturer report number: 1644487-2012-01583. The nurse believes the two patient's increased seizures are acute situations. Follow up with the nurse revealed that she was mistaken regarding some of the reports, and it is unclear if she still suspects an issue with the model 103 generators. Attempts for clarification have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2565092
Report Number1644487-2012-01171
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2013
Device MODEL Number103
Device LOT Number201761
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/30/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/02/2011
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: 05/08/2012 Patient Sequence Number: 1
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