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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 12/30/2011
Event Type  Injury  
Event Description

Our local partner in (b)(6) was contacted by a treating physician and it was reported that after a patient received their vns therapy on (b)(6) 2011, seizure control has become poor. The number of their average seizure attacks has increased from 4. 9 to 27. 4 /per day. Also, the seizure type has become more serious (for example: absence seizure attack combines silly laugher or shouting, it hasn¿t happened before vns implanted). Moreover, by family's concern and physician's experience, physician has changed the parameter setting frequently (2wks). The patient's seizure control has become worse. Good faith attempts are underway for further details about the reported events.

 
Event Description

Additional information was received that the patient did not have any change in medications prior to their increased seizures. Titrations of therapy were made as follows. They were set at 1ma, 30hz, 500msec, 30sec, 5min on (b)(6) 2012. The physician assessed the stimulation may be too high, so he decreased the stimulation and the setting was 1ma, 25hz, 500msec, 30sec, 5min. The seizure control was still poor and their absence seizures increased, so the last parameter setting was changed (b)(6) 2012, which is 1. 25ma, 25hz, 500msec, 30sec, 5min. The seizure control has improved little bit since that time. They plan on monitoring the seizure control of this case. The final system diagnostic was at (b)(6) 2012, which result is normal. No further information has been attained.

 
Event Description

It was reported that the patient's seizures are progressively getting worse. Device diagnostics in september 2014 were within normal limits. Device settings options were discussed. No additional relevant information has been received to date.

 
Manufacturer Narrative

Adverse event or product problem: corrected data to serious injury. Type of reportable event - corrected data to serious injury.

 
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Brand NamePULSE GEN MODEL 103
Type of DevicePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key2867808
Report Number1644487-2012-03288
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/13/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2012
Device MODEL Number103
Device LOT Number201602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/04/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/13/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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