MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

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.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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 Key: 3854192
• MDR Text Key: 4681003
• Report Number: 1644487-2014-01427
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2011
• Device Model Number: 302-20
• Device Lot Number: 2164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR