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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 05/01/2012
Event Type  Injury  
Event Description

On (b)(4) 2013 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2013 indicated that the vns patient has experienced clusters of myoclonic seizures and head drops since (b)(6) 2012. It was stated that the myoclonic seizures were occurring 2-4 times a day but now he has them once a day. It was also stated that patient has been experiencing myoclonus seizures twice per week which the mother thinks is new, but previous clinic notes indicate longstanding myoclonus. The patient¿s vns settings were noted to be output=1ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet pulse width=250usec/magnet on time=60sec. A system diagnostics test was also performed which showed results within normal limits and eos=no. The clinic notes also mention that the patient is experiencing an increase in the frequency of his tonic seizures, especially at night. The patient was referred for generator replacement for an unknown reason. Additional information has been requested from the patient¿s physician but no further information has been received to date. A battery life calculation was performed which showed 5. 74 years remaining until eri=yes.

 
Event Description

Additional information was received that the patient had a generator replacement. Attempts for product return have been unsuccessful to date.

 
Event Description

The explanted device was returned on (b)(4) 2013. In (b)(6) 2013 notes, a system diagnostics test was also performed which showed results within normal limits and eos=no. Therefore, the event coding was not updated to indicated neos. Although the reported allegation of ¿change in seizure pattern¿ and ¿increased seizures¿ listed in (b)(4) cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. 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. The generator performed according to functional specifications as defined in final electrical test (b)(4). During the product analysis there were no anomalies found with the pulse generator. Attempts for additional information were unsuccessful.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 Key3192307
Report Number1644487-2013-01940
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/05/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2007
Device MODEL Number102
Device LOT Number012303
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/20/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/20/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/21/2005
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: 06/27/2013 Patient Sequence Number: 1
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