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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 03/01/2015
Event Type  Injury  
Event Description

It was reported that the patient was experiencing an increase in seizures characterized by myoclonic jerking. These started approximately one year prior to the beginning of their mention in the clinic notes (date of notes was (b)(6) of 2016). The physician attributed the increase in seizures to battery depletion. The physician expressed he would seek generator replacement for the patient. Surgical intervention has not occurred to date. Follow up with the office of the treating physician¿s office showed that they suspected the battery to be low, but could not identify if the generator registered a low battery indicator at that time. Device diagnostics from that time could not be indicated. The patient was reportedly not taking any antiepileptic drugs, but this was not a recent change and could not be linked to the increase in seizures. No other relevant information could be provided at that time.

 
Event Description

The patient's generator replacement surgery occurred on (b)(6) 2016. Prior to explant, the patient's battery was reported to not be at end of service, and the device diagnostics were within normal limits. The explanting facility does not return explanted devices; therefore, product return attempts could not be completed. No additional pertinent information has been received to date.

 
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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 Key5947422
Report Number1644487-2016-02068
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2007
Device MODEL Number102
Device LOT Number014911
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/31/2006
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: 09/13/2016 Patient Sequence Number: 1
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