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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Injury  
Event Description

Report received that a patient presented with an increase in seizures in the clinic. During the same visit, it was reported that the patient did not feel magnet mode stimulation and the magnet no longer affected her seizures. The generator was also unable to be interrogated by the physician's programmer. This combination of events reportedly led the physician to believe the device had reached end of service and resulted in the referral for generator replacement surgery. At the patient's previous appointment about 6 months before, there was no indication the generator's battery was depleting. The vns settings were also provided from the interrogation performed during that appointment. The patient not feeling her magnet was also reported to have occurred during this previous appointment. System diagnostic results and pre-vns frequency levels were not provided. The physician's programmer was reportedly able to interrogate other generators after having a failure on this patient's generator. No surgical intervention has occurred to date. No further relevant information has been provided to date.

 
Event Description

Further information was received that the patient's generator was replaced. The generator has not been received by the manufacturer to date. No further relevant information has been obtained.

 
Event Description

Further information was received that the generator had been received for product analysis by the manufacturer. This analysis was later completed. Visual inspection did not identify any surface anomalies outside of the typical markings associated with implant and explant procedure. The device was able to be interrogated and system diagnostic testing was successfully performed. All results were normal. A test using magnet activation and disablement found that the reed switch was operating as expected. The generator was also tested in a simulated bodily environment and no changes or variations in output current were identified. A comprehensive automated electrical evaluation also showed that the pulse generator performed according to functional specifications. The data from the generator also did not show any anomalies. Proper functionality of the generator in its ability to provide appropriate programmed output currents was verified in product analysis. Updated programming data was also reviewed. The only available data was from the day of explant but it showed that the impedance was within normal limits. The battery status was also found to be functional. No additional relevant information has been received.

 
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Brand NamePULSE GEN MODEL 103
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 Key7077230
Report Number1644487-2017-04910
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/05/2015
Device MODEL Number103
Device LOT Number3713
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/03/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/03/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/27/2013
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: 12/01/2017 Patient Sequence Number: 1
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