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

Model Number 302-20

Device Problem Kinked (1339)

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

Event Date 09/28/2015

Event Type  malfunction  

Event Description

It was reported the lead was replaced due to an observed kink during surgery.The vns generator was replaced due to normal battery depletion.Both the lead and the generator were received for analysis.Analysis is expected, but has not been completed to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Product analysis for the generator was completed.It was found that the generator was at the eos (end of service) condition.The depletion was an expected event as determined by the battery life calculation and the battery voltage measurement.There device performed according to specifications.

Event Description

Product analysis was completed on the returned portion of the lead.Analysis of the returned portion of the lead determined that the report of a kinked lead was not verified.However, a large portion of the lead assembly (body), including the electrodes, was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.The abraded opening found on the outer silicone tubing and the cut ends that were made during the explant process 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 ends that were made during the explant process.What appeared to be white deposits were observed in various locations.Chemical analysis was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicone.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pins 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 and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.

• 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: 5176644
• MDR Text Key: 29846363
• Report Number: 1644487-2015-06222
• 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,Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2015
• 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: 7469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2002
• 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: 30 YR