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

Model Number 302-20

Device Problems Break (1069); Battery Problem (2885); Moisture or Humidity Problem (2986)

Patient Problem No Code Available (3191)

Event Date 08/10/2015

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2015 that the patient was having a replacement for battery depletion.The impedance value was measured prior to the case and was ok.When the surgeon opened up the pocket he noticed that the lead was nicked and there was fluid inside of it.The devices were discarded after surgery and will not be returned for analysis.

Manufacturer Narrative

Describe event or problem; inadvertently reported that the devices were discarded after surgery.Evaluation codes, conclusion; inadvertently reported code that device was discarded.

Event Description

The generator and lead were not discarded and were returned for analysis on 08/25/2015.Analysis is currently underway but has not been completed to date.

Event Description

Product analysis for the generator was completed and approved on 09/23/2015.During analysis it was found that the generator was pulse disabled.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant.Review of the device decoder data downloaded from the generator shows that on (b)(6) 2015 (date of explant) the impedance value changed from 1764 ohms to 20879 ohms.The vns programming history database shows the last known diagnostic test was performed on (b)(6) 2015 with an impedance value of 1778 ohms.Other than the noted event (pulsedisabled), there were no additional performance or any other type of adverse conditions found with the pulse generator.Product analysis for the lead was completed and approved on 09/24/2015.The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The abraded opening, incision and slice marks found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in lab, there is no evidence to suggest discontinuities in the returned portion of the device.

Event Description

Information was received on 05/13/2016 from operative notes from the date of explant (b)(6) 2015.It was stated that the lead to the vagal nerve stimulator had loss of integrity.There was fluid inside of the costing around the lead up and down the lead of the device.It was noted on inspection of the lead that there was fluid in the lead extending to the generator.They them identified an opening in the elastic tubing surrounding the lead wires which allowed for an ingress in fluid.With this finding, a decision was made to replace the lead.

• 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: 5025285
• MDR Text Key: 24711168
• Report Number: 1644487-2015-05598
• 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: Health Professional
• Type of Report: Followup,Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/15/2015; 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2005
• 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: 24 YR