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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 08/30/2013
Event Type  Malfunction  
Event Description

Clinic notes dated (b)(6) 2013, indicate the patient experienced an increase in seizures likely due to the high impedance on the vns. Seizure frequency is reported as six to eight per day, or twenty to thirty per month. The vns device was turned off due to the high impedance and vns replacement surgery is being considered. Per the patient's vns continues to work well for the patient and the family still feels that swiping the magnet is helpful. The patient continues to have two seizure types and had decreased his seizures to one to four seizures every few days (may cluster four to eight a week). These are all tonic seizures. The seizures are preceded by an attempt to find comfort. In the past two months, a drastic increase in diastat use was noted. Increased keppra has helped in the past and stopped a new seizure type in (b)(6). The seizures are worse in the morning and sometimes a cluster may get close to five minutes. The keppra medication was increased and lamictal dose stayed the same. Although the clinic notes indicate that the same seizure frequency is both an increase and decrease, follow up with the nurse verified that the patient did experience an increase in seizures related to the high lead impedance. The nurse stated that the decrease in seizures to one to four seizures every few days was written in clinic notes dated (b)(6) 2013. Diagnostics were within normal limits at that time. Per the mother, the patient did not have any trauma or manipulation of the leads and had not sustained any falls that may have caused the high lead impedance. There were no causal factors for the increased seizures except the high impedance. The nurse was unable to distinguish the patient's increased seizure frequency to pre-vns baseline levels. The patient had a ches x-ray on (b)(6) 2013 which showed no abnormalities in the visualized portion of the lead. The x-rays will not be sent to the manufacturer for review. Although surgery is likely, it has not yet occurred.

 
Manufacturer Narrative

Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key3381597
Report Number1644487-2013-03007
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/04/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2008
Device MODEL Number302-20
Device LOT Number1330
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/04/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/10/2005
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: 10/02/2013 Patient Sequence Number: 1
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