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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 07/31/2014
Event Type  Malfunction  
Event Description

It was reported that the patient was experiencing pain in the neck since generator replacement on (b)(6) 2014. It was reported that the pain was constant and was not only occuring with device stimulation. The patient's generator was programmed off which did not resolve the pain. The patient was scheduled for revision surgery. The patient underwent surgery at which time the surgeon identified that the lead was frayed. It was reported that device diagnostics did not show high impedance. The lead was replaced. The lead was received for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

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

 
Event Description

It was reported that the patient's device has not been programmed back on yet. The patient is no longer experiencing pain in the neck. It was reported that the pain was more of an all over pain and was not related to vns. The patient believes that the use of a heating pad on the neck contributed to the discomfort.

 
Event Description

Analysis of the lead was completed on 10/09/2014. Note that the electrodes were not returned for analysis, with the exception of the spot-weld / slug still attached to the end of the (+) connector ring quadfilar coil and therefore a complete evaluation could not be performed on the entire lead product. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the (+) connector ring quadfilar coil attached to a portion of the ribbon. 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 / torn ends that were made during the explanted process. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

 
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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 Key4101523
Report Number1644487-2014-02391
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/20/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2008
Device MODEL Number302-20
Device LOT Number1285
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/16/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/14/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/13/2005
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: 09/19/2014 Patient Sequence Number: 1
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