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

Model Number 302-20

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Mechanical Problem (1384); Low impedance (2285)

Patient Problem No Information (3190)

Event Date 08/12/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

Patient underwent generator replacement on (b)(6) 2016 and the lead impedance at the time of implant was 687 ohms.The patient had a follow up visit on (b)(6) 2016 and after interrogation, the impedance shown was below 600 ohms, indicating low impedance (< 600 ohms).No known interventions were taken since the patient is receiving efficacy.The impedance will be monitored during each clinic visit.

Manufacturer Narrative

Relevant tests/laboratory data, including dates; corrected data: (b)(6) 2016 09:19:46 am: diagvinitialprechange ¿ 483 ohms / diagvinitialpostchange ¿ 650 ohms / time of change detection ¿ (b)(6) 2016 16:17 estimated occurrence (implant (b)(6) 2016).Initial mdr inadvertently indicated the implant date to be (b)(6) 2016 instead of (b)(6) 2016.

Event Description

Additional programming data was received.

Event Description

Additional programming data was received.

Event Description

Patient underwent lead revision surgery on (b)(6) 2016.The generator was tested with the resistor pin and the impedance was 3246 ohms.The lead wire was noticeably frayed and thus a new lead was implanted.Impedance on new lead when connected to the existing generator was 1029 ohms.The explanted lead was received on 11/28/2016.Analysis is underway but has not been completed to date.

Event Description

Abraded openings were noted on the outer and the inner silicone tubing of the lead coils resulting in portions of the lead coils being exposed.A break was identified in the positive coil.Scanning electron microscopy images of the positive coil broken ends show what appears to be wear (flat surfaces) on the coils strands resulting in reduction of the diameter of the quadfilar coil strands up to the point of break.Also, scanning electron microscopy images of the lead coils at the suspected torn ends of the first portion of the returned lead show appearance suggesting that the coils were exposed to some type of electro-cautery tool (most likely at explant).One strand shows appearance suggesting that the coils were torn.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 other anomalies were identified in the returned lead portions.

• 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: 5934938
• MDR Text Key: 54651199
• Report Number: 1644487-2016-02014
• 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,Followup,Followup
• Report Date: 03/07/2017

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: 07/22/2006
• Device Model Number: 302-20
• Device Lot Number: 011003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/19/2016; 09/30/2016; 11/14/2016; 12/14/2016; 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2004
• 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: 19 YR