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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 01/01/2015
Event Type  Injury  
Event Description

It was reported that the patient was referred for generator replacement due to an increase in seizures above the patient's pre-vns baseline frequency. It was reported that the increase in seizures have resulted in head injuries and that the referral for surgery was prophylactic based on the seizures and amount of time the generator had been implanted. The physician reported that device diagnostics were within normal limits. The patient underwent generator replacement. The explanted generator has not been received for analysis 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
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 Key4650197
Report Number1644487-2015-04339
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/12/2013
Device MODEL Number103
Device LOT Number201848
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/10/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/15/2011
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: 04/01/2015 Patient Sequence Number: 1
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