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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 01/06/2015
Event Type  Injury  
Event Description

It was reported that the vns patient experienced a drop attack and blacked out following a magnet swipe. It was noted that this seizure type was not typical for the patient. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

Additional information was received that the patient's reported episode is not a new seizure type, unknown cause for episode (drop attack with lips turning blue). No interventions were taken. Medications taking at the time of the event. Depakote-6. 25 mg bid / fycompa 8 mg qhs / zonisamide-150 mg qhs / banzel 17. 5 ml in am, 3. 5 ml in afternoon , 7 ml evening / onfi-5 mg bid.

 
Manufacturer Narrative

 
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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 Key4483657
Report Number1644487-2015-03749
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/04/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2015
Device MODEL Number103
Device LOT Number3546
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/11/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/31/2013
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: 02/04/2015 Patient Sequence Number: 1
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