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

Model Number 302-20

Device Problems Fluid/Blood Leak (1250); High impedance (1291)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/01/2016

Event Type  malfunction  

Event Description

The surgeon reported finding high impedance on the patient's generator during a visit on (b)(6) 2016.There was no known trauma, but it was stated that trauma was "certainly possible given his condition".No revision surgery for the high impedance has occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient's underwent full revision of generator and lead due to high impedance.The suspect product was received for analysis.No further relevant information has been received to date.

Event Description

Analysis was completed on the generator and lead.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.No anomalies were found, the internal data of the generator was reviewed and found that the last 25% change in impedance occurred on (b)(6) 2017 from impedance within normal limits (4281 ohms) to high impedance (5633 ohms).This suggests an intermittent lead fracture with fluctuating high impedance as high impedance was detected prior to (b)(6) 2017.Product analysis was completed on the lead.The lead assembly was returned in two portions.The electrode array was not returned, so a complete analysis could not be performed on the product.Set-screw marks were observed on the lead pin, which indicates that at one point in time there was a good electrical and mechanical connection between the lead and generator.There were multiple instances of abraded openings of the inner tubing and of the inner and outer tubing.Portions of the quadfilar coil were exposed.There were bodily fluids found in both the inner and outer tubing that were attributed to these openings.The cause of these abraded opening was determined to be wear.A lead fracture was nit found on the returned portions.Beyond the abraded openings, the condition of the lead was typical of that of leads after explant.No further anomalies found.No further relevant information has been received to date.

• 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: 6119283
• MDR Text Key: 60904592
• Report Number: 1644487-2016-02702
• 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: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2004
• Device Model Number: 302-20
• Device Lot Number: 5986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2002
• 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: 42 YR