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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 10/02/2014
Event Type  Malfunction  
Event Description

Clinic notes were received on (b)(6) 2014. Clinic notes dated (b)(6) 2014 indicate that the patient was having starring spell seizures almost daily and that swiping the magnet stopped his seizures. The patient¿s vns showed high impedance. It was noted that the patient would be referred for x-rays and surgery. Clinic notes dated (b)(6) 2014 indicate that the patient had several small seizures and that he was doing well with seizure control until his trigeminal neuralgia started. The neurologist stated that once his trigeminal neuralgia pain is resolved he thinks his seizure frequency will return to baseline levels.

 
Event Description

On 12/08/2014 product analysis was completed on the lead. A portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis was completed on the generator on 12/11/2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Event Description

On (b)(6) 2014, it was reported that high impedance was observed that day for the patient during a system diagnostics test. The patient was sent for a chest and neck x-ray and the device was disabled. The patient was referred for a full revision. Although surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

On (b)(4) 2014 it was reported that the patient was scheduled for a full revision surgery. Surgery took place on (b)(6) 2014. The explanted generator and lead were returned for product analysis on (b)(4) 2014. Product analysis is still underway and has not yet been completed.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key4154445
Report Number1644487-2014-02589
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 10/02/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/09/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2014
Device MODEL Number302-20
Device LOT Number2567
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/25/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/05/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/10/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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