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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 05/20/2013
Event Type  Death  
Event Description

It was reported that the cause of death was due to seizure disorder as a result of a blunt force trauma from a motor vehicle accident. It was reported that the patient was still experiencing seizures at the time of death. It was unknown if the death was a result of a terminal seizure. The generator and lead were returned for analysis on (b)(6) 2013. The generator analysis was completed on (b)(4) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The lead analysis was completed on (b)(6) 2013. Note that the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, zirconium and calcium. Refer to attached eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified.

 
Manufacturer Narrative

 
Event Description

A coroners office called to obtain a returned goods number for an explanted generator. It was reported that it can take up to a month to have the product returned. Thus far it has not been returned. At this time it is unknown the cause of the patient's death. Autopsy results are pending completion. The death was non traumatic but no other information known at this time. Good faith attempts will be made for more information as it becomes available for release.

 
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Brand NamePULSE GEN MODEL 102R
Type of DevicePULSE GEN MODEL 102R
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 Key3188401
Report Number1644487-2013-01913
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/28/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date12/31/2009
Device MODEL Number102R
Device LOT Number200693
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2013
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/22/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/10/2008
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: 06/25/2013 Patient Sequence Number: 1
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