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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 04/14/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance. The patient had recently undergone generator replacement. Device programming history was received from the handheld used during surgery which indicated that the high impedance was present with the new generator attached to the existing lead. Clinic notes dated (b)(6) 2014 note that high impedance was observed and that the patient would be referred to surgeon. The notes indicate that during the generator replacement surgery the battery was functioning appropriately; however, the lead impedance continually returned elevated. It was noted that the explanted generator was dead; therefore the high impedance was not observed prior to generator replacement. The patient is scheduled for surgery to correct the high impedance; however, the surgery has not occurred to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Analysis of the returned lead portion was completed. No discontinuities were identified within the returned lead portion. The lead assembly has dried remnants of what appear to have once been body fluids/betadine solution inside the inner silicone tubing. No obvious point of entrance was noted other than the end of the returned lead portions. Incisions in the silicone tubing of the returned lead portions were necessary to perform proper inspection of the lead coils. The in-line lead connector has single setscrew mark at the end tip of the connector pin suggesting that the lead connector was not inserted completely at one point in time. The exact point in time of when this occurred is unknown. Although not conclusive, this condition may confirm to be a contributing factor to the reported high impedance. Based in the location of the one complete set of setscrew marks present on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator ¿+¿ and ¿¿¿ terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. The lead connector was inserted completely in a representative pulse generator header and no anomalies that could prevent proper insertion were identified. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portions.

Event Description

It was reported that the patient underwent lead replacement surgery. Device diagnostics with the new lead attached to the existing generator was within normal limits (1600 ohms). The explanted lead was received for analysis. Analysis is underway, but has not been completed 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.

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.

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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3854192
Report Number1644487-2014-01427
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/08/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2011
Device MODEL Number302-20
Device LOT Number2164
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/16/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/11/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/19/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial