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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
Event Date 12/14/2012
Event Type  Injury  
Event Description

On (b)(6) 2013 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2012 indicated that the patient has been experiencing an increase in seizures along with an increase in seizure intensity. It was noted that the patient has 4-6 gtcs daily and they have increased around sleep and with menses; prior to that the patient had only absence seizures. The patient's settings were: output=1. 5ma/frequency=30hz/pulse width=500usec/on time=30ec/off time=3min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=500usec. The patient was referred for surgery due to an unknown reason. Although surgery is likely, it has not occurred to date. Good faith attempts for further information from the physician have been unsuccessful.

 
Event Description

On (b)(6) 2013 the explanted generator was received for product analysis. Product analysis is still underway and has not yet been completed.

 
Event Description

Product analysis on the explanted generator was completed on (b)(4)2013. In the pa lab, the device output signal was monitored for more than (b)(4), 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. The battery, 2. 777 volts as measured during completion of the final electrical test, shows an ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Additional information was received when it was discovered that the patient underwent a battery replacement surgery on (b)(6) 2013. It was reported that the explanted generator would be returned to the manufacturer for product analysis, however it has not been received to date.

 
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Brand NamePULSE GEN MODEL 103
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2979716
Report Number1644487-2013-00528
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/06/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2010
Device MODEL Number103
Device LOT Number200871
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/02/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/29/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/22/2008
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: 02/27/2013 Patient Sequence Number: 1
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