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

Model Number 302-20

Device Problems High impedance (1291); Battery Impedance Issue (2884)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

The surgeon's office reported that the patient was to undergo a full system revision due to high impedance of the lead.Generator was to be replaced due to battery depletion.During pre-operative interrogations the generator battery was found to be depleted and therefore could not be interrogated.However the old lead was tested with the new generator and high impedance was found.The lead was replaced and the diagnostics were within normal limits for the new system.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.To date the product has not been returned for analysis.

Event Description

Further follow-up found that troubleshooting to resolve the high impedance was performed when the new generator was connected to the existing lead which did not resolve the high impedance; therefore, the lead was also replaced.The generator and lead were received for analysis.Analysis of the lead was completed on 04/05/2016.Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.The quadfilar coil was broken in several places.The coil had signs of fatigue stress and pitting which is indicative that stimulation occurred after the coil fractured.With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.Analysis of the generator was completed on 04/07/2016.Analysis identified that the high impedance began on (b)(6) 2015.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 5504360
• MDR Text Key: 40843406
• Report Number: 1644487-2016-00567
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2004
• Device Model Number: 302-20
• Device Lot Number: 7541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2002
• 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: 32 YR