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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 01/23/2015
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in low impedance (<600 ohms) and that the patient has experienced worsening seizures. The patient was referred for lead replacement. The patient underwent lead replacement on (b)(6) 2015. It was reported that device diagnostics with the new lead and existing generator were within normal limits. The explanted lead has not been received for analysis to date. No additional relevant information has been received to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

The explanted lead was returned for analysis on (b)(4) 2015. Product analysis for the lead was completed and approved on (b)(4) 2015. An analysis was performed on the returned lead portions and a condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations. The bare and exposed conductive coils may be a contributing factor. Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Abraded openings were observed on the outer silicone tubing and both of the inner silicone tubes. The quadfilar coils appeared to be stretched, kinked and bare, in some areas. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to 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 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 Key4531971
Report Number1644487-2015-03918
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial,Followup
Report Date 01/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2008
Device MODEL Number302-20
Device LOT Number1354
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/10/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/21/2005
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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