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U.S. Department of Health and Human Services

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

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CYBERONICS INC PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 10/03/2013
Event Type  Injury  
Event Description

On (b)(6) 2014, it was reported that the patient¿s device was still disabled and that the patient was referred for full revision due to a report of painful stimulation. The surgery was both for patient comfort and to preclude a serious injury: the patient was now experiencing an increase in seizures due to the device being programmed off. It was initially reported that this patient was experiencing an increase in seizures related to menopause. The patient didn¿t feel stimulation all the time like she used to and only felt it when diagnostics were performed. It was presumed that the patient just became used to the settings. Ap and lateral chest x-rays dated (b)(6) 2013 were received and reviewed on (b)(6) 2013. The reason for the exam, per attached documentation, was vns placement and possible lead breakage. X-rays showed that the generator is visible in the left chest and is normally placed. The lead pins appear fully inserted into the connector blocks. The feedthru wires appear intact. The lead wire at the connector pins appears intact. Lead is present behind the generator and cannot be assessed. The lead wire is seen routing up towards the left neck. The electrodes appear normally placed. No gross fractures, lead discontinuities, or sharp angles are present. Based on the images present, the generator placement appears normal, and no lead discontinuities appear to be present. It was later reported that the patient¿s device was currently off, and the patient was to undergo an mri. The device had been disabled because the device was shocking the patient. When the patient used the magnet, nothing happened, even when she wasn¿t having a seizure. Additional clarification showed that it was unknown if the painful stimulation and magnet events were occurring with stimulation. Sometimes the patient would be sitting or lying down, and would experience the ¿shocking. ¿ the patient¿s device had been disabled since (b)(6) 2013 due to the shocking. The patient didn¿t feel the stimulation from magnet activations (stimulation not perceived). The patent had previously experienced choking with stimulation when she was eating or drinking, but she knew this feeling now, and the shocking was different and painful. The patient¿s father believed that the problem would resolve with replacing the patient¿s whole system with the newest model. Surgery is likely but has not taken place.

 
Manufacturer Narrative

Review of programming history; manufacturer reviewed x-rays of implanted device; x-rays reviewed by the manufacturer, no gross lead discontinuities or anomalies visualized.

 
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Brand NamePULSE GEN MODEL 102R
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 Key4358279
Report Number1644487-2014-03462
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/19/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2009
Device MODEL Number102R
Device LOT Number017152
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/19/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/17/2007
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: 12/23/2014 Patient Sequence Number: 1
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