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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
Device Problem Insufficient Information
Event Date 05/05/2015
Event Type  Injury  
Event Description

It was reported that the patient experienced an unusual seizure during device settings adjustments; therefore, the physician left the settings as previously programmed. The patient reported that the seizure was different than what she was used to. Attempts to obtain additional relevant information have been unsuccessful to date. The relationship of the unusual seizure to vns is unknown.

 
Manufacturer Narrative

The previously submitted mdr inadvertently provided an incorrect event date.

 
Event Description

Information was received from the neurologist via a company representative on (b)(6) 2015. The date of onset of the new seizure type was (b)(6) 2015. The patient's seizures are less severe since vns. The new seizure type is not related to vns, but is related to external factors. No interventions were planned or taken. Diagnostic results were not reported.

 
Event Description

Further reports regarding this patient's increased seizures were received and this and all further relevant information regarding this event will be captured mfr. Report # 1644487-2017-03470.

 
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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 Key4860270
Report Number1644487-2015-04964
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2012
Device MODEL Number102
Device LOT Number2916
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/14/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/11/2011
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: 06/22/2015 Patient Sequence Number: 1
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