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

Model Number 302-30

Device Problem Insufficient Information (3190)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/13/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported on 05/25/2016 that the patient reports having a shocking feeling in her chest area.The neurologist will consult with the surgeon about a possible lead or full revision.The patient went to the er (b)(6) 2016 and the vns was programmed off which resolved the issue.It was stating the diagnostics showed dcdc-0 at (b)(6) 2016 so at the time of the call it was not clear if there was a short circuit.She said that the pocket stimulation never completely went away after his generator was replaced in 2013.It did get significantly better after surgery but it has gotten progressively more bothersome over time.This seems to support the theory about an abraded opening in the lead.No additional information has been received to date.

Event Description

Device diagnostics were ran and there was no lead impedance and everything seemed fine, however patient experienced pain near generator.Full revision is planned but has not been completed to date.

Event Description

An implant card was received indicating that the patient had replacement surgery on (b)(6) 2016 due to prophylactic replacement and lead discontinuity.The explanted devices have not been received for analysis to date.

Event Description

The generator and lead were received for analysis on 10/26/2016.Product analysis for the generator was completed and approved on 11/03/2016.The device performed according to functional specifications.Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.Analysis for the lead is currently underway but has not been completed to date.

Event Description

Product analysis for the lead was completed and approved on (b)(6) 2016.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device which may have contributed to the low impedance.

• 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: 5733663
• MDR Text Key: 48510506
• Report Number: 1644487-2016-01383
• 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: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/02/2012
• Device Model Number: 302-30
• Device Lot Number: 2309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2009
• 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: 16 YR