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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Device Problem Insufficient Information
Event Date 07/02/2015
Event Type  Death  
Event Description

It was reported that a vns patient died. No information is available to date regarding the circumstances around the patient's death. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The vns system was explanted postmortem. The explanted devices were received by the manufacturer; analysis of the devices is underway, but it has not been completed to date.

 
Event Description

An analysis was performed on the explanted generator, 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. Analysis in the pa lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found.

 
Event Description

An analysis was performed on the returned lead portions. 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 on the deposit observed on the unmarked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. 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, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Event Description

Review of available vns device programming history by the manufacturer indicates that the device was switched off on (b)(6) 2006. The explanted device was received by the manufacturer as programmed off and analysis showed the battery was not depleted. There is no evidence from the available information the device was ever turned on again and the patient was most likely not receiving vns therapy at the time of the death.

 
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Brand NamePULSE GEN MODEL 101
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 Key5406289
Report Number1644487-2016-00217
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2004
Device MODEL Number101
Device LOT Number7812
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/01/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/16/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/19/2003
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: 02/03/2016 Patient Sequence Number: 1
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