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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102R GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Injury  
Event Description

It was reported that the patient was having recurring seizure activity. The er attempted to interrogate the vns generator several times but was unsuccessful. Previous information in clinic notes received by the manufacturer indicated that the patient¿s generator was at end of service. The increase in seizures was attributed to a loss of vns therapy due to the battery depletion. The patient underwent vns generator replacement surgery due to the suspected battery depletion. The explanted generator was received by the manufacturer and product analysis was completed. The reported ¿end of service¿ allegation was not confirmed in the pa lab, although the elective replacement indicator flag was set. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the battery was ¿partially depleted¿. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion. The reported ¿failure to program¿ allegation was not duplicated in the pa lab. In the pa lab, the device output signal was monitored for more than 24 hours, 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. The device performed according to functional specifications. There were no performance or other adverse conditions found with the generator. Follow up with the physician's office revealed that the increase in seizures occurred around when the office was unable to interrogate the patient's vns, which lead them to believe it was fully depleted. They were unable to provide an assessment on the comparison of the increase in seizures to the pre-vns baseline or its relation to vns. The last interrogation of the vns was approximately half a year prior and it was stated that the settings were stable and no changes were made to the programmed settings. It was indicated that diagnostics at the time indicated that the vns was "not as end of service". No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8241996
Report Number1644487-2019-00055
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/26/2007
Device MODEL Number102R
Device LOT Number014788
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/28/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/26/2006
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: 01/11/2019 Patient Sequence Number: 1
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