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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 102 GENERATOR

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CYBERONICS PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 04/23/2015
Event Type  Injury  
Event Description

It was reported that the vns patient had presented increased seizures for 6 weeks. It was reported that the patient had benefited from vns therapy when the duty cycle was increased from 16% to 29%. Night seizures had not occurred since (b)(6) 2015 after the increase in the duty cycle. The night seizures occurred again six weeks earlier and the patient also presented complex partial seizures during the day, after waking up, with anxiety, rapid heartbeat, panting, stiffening of the arms and partial loss of conscience, being able to hear but not to respond. It was also reported that the vns generator was interrogated and the output current was found at 1ma while it had been programmed at 2ma in the last follow up visit, with the rest of the settings unchanged: frequency 25 hz, pulse width 500usec, 21sec on time, 1. 1min off-time, magnet output current 2. 25ma. The patient¿s device was tested and system diagnostics returned impedance results within normal limits with dcdc 2 and normal mode diagnostics returned dcdc 5. It was reported that the impedance results were the same as in (b)(6) 2015. It was reported that the output current was set to 2ma and the duty cycle was increased from 29% to 36% with 21sec on-time and 0. 8min off-time. The patient had not noticed when vns stimulation did not alter the voice any longer. The patient is (b)(6) years old and has had epilepsy since her (b)(6) year. During the first year she had several seizures per year over a period of 3-4 weeks with anxiety seizures and milder seizures with rapid onset of abdominal pain with paleness without loss of consciousness and generalized tonic-clonic seizures. From her (b)(6) year she presented mainly 3 night seizures per week w, no longer in clusters. The epilepsy is mri negative, with both temporal as frontal symptoms. Review of the available programming and diagnostic history showed normal diagnostic results and no programming anomalies through (b)(6) 2015. Review of manufacturing records confirmed that the generator and the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that both the generator and the lead passed all functional tests prior to distribution.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
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 Key4874298
Report Number1644487-2015-05042
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2014
Device MODEL Number102
Device LOT Number202303
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2012
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: 06/29/2015 Patient Sequence Number: 1
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