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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 01/12/2015
Event Type  Malfunction  
Event Description

It was reported that the recently implanted vns patient experienced successive seizures nonstop for 30 minutes. The patient was taken to the or and the seizures stopped at that time. The patient¿s device output current was increased from 0. 25ma to 0. 5ma earlier that day. No intervention was taken. It was noted that the patient had not previously experienced seizures of this type. No medication changes preceded the onset of the event. Prior to vns, the patient averaged three seizures per day. Diagnostic results showed normal device function at the time of implant. The physician indicated that all of the patient¿s seizure types had increased. The patient was reported to be stable now.

 
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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 Key4491065
Report Number1644487-2015-03769
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/13/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number102
Device LOT Number3996
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/26/2014
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: 02/06/2015 Patient Sequence Number: 1
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