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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 08/21/2014
Event Type  Malfunction  
Event Description

Analysis of the returned lead portion was completed. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed and no discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

 
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

It was reported that the patient underwent lead replacement surgery. An implant card was received confirming that only the lead was replaced and that the lead impedance with the new lead and existing generator was within normal limits. The explanted lead was received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

It was reported that device diagnostics resulted in high impedance. It was reported that no trauma occurred to the lead area. It was reported that previous diagnostics had been within normal limits (< 2,000 ohms). The physician programmed the device off after observing the high impedance. X-rays were taken and sent to manufacturer for review. Review of x-rays did not identify any obvious discontinuities with the vns system. No known surgical intervention has been performed to date.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.

 
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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 Key4115369
Report Number1644487-2014-02455
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/26/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2014
Device MODEL Number302-20
Device LOT Number2658
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 Received12/15/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/06/2010
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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