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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 01/12/2016
Event Type  Malfunction  
Event Description

It was reported that high impedance (dcdc-7) was observed on vns patient's system. The device was then switched off. X-rays were taken and sent to manufacturer for review. Review of the x-rays identified that the lead pin was fully inserted into the generator header. The filter feed-through wires appeared to be intact. Part of the lead appeared to be behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the part of the lead that could be assessed. A micro-fracture could not be ruled out. Further information from the physician was received indicating that the patient had a big fall with chest impact on a door, in early (b)(6) 2016, due to seizure. Since, the magnet is no longer effective. It was reported that the patient has an increase in seizures at pre-vns level. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. It was reported that an intervention is planned. No known surgical interventions have been performed to date. No additional relevant information has been received to date.

 
Manufacturer Narrative

The previously submitted mdr inadvertently provided the wrong conclusion codes for the event.

 
Event Description

Further information was received indicating that the patient underwent a full replacement surgery on (b)(6) 2016. The lead was replaced due to high impedance. The generator was replaced due battery depletion. It was reported that the vns new system was implanted in the right side of the patient's body. The explanted lead will not be returned to the manufacturer as it was discarded by the facility. Therefore, no analysis could be performed. The explanted generator was returned to the manufacturer on (b)(6) 2016. Analysis of the returned generator was completed. The reported battery depletion was not duplicated in the product analysis laboratory. 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. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Further information was received indicating that the patient is subject to a vns study. It was reported that the patient had status epilepticus from (b)(6) 2016. It was reported that the severity of the event was mild. The event was not related to implant but possibly related to vns stimulation. It was reported that the treatment was modified and as other action taken: a lead replacement. It was reported that the event was a serious adverse event since it resulted in an initial or prolonged hospitalization. But it did not cause the subject to discontinue from the study. Additional information indicated that the patient had status epilepticus in the period when high impedance was observed. Therefore, the physician concluded that there was a relationship between both events. Both events are now solved.

 
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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 Key5406587
Report Number1644487-2016-00218
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type STUDY
Reporter Occupation
Type of Report Followup,Followup,Followup
Report Date 01/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2017
Device MODEL Number302-20
Device LOT Number202731
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/30/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/21/2013
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: 02/03/2016 Patient Sequence Number: 1
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