MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

Model Number 303-20

Device Problems Corroded (1131); High impedance (1291); Mechanical Problem (1384)

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

Event Date 05/15/2012

Event Type  malfunction  

Event Description

Patient underwent generator and lead explant surgery due to lack of efficacy.The devices were returned for analysis.In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.In the lead assembly returned for analysis, an abraded opening was noted on the silicone tubing resulting in portion of the positive coil being exposed.Scanning electron microscopy images of the connector pin and connector ring show that pitting or electro-etching condition have occurred on both the connector pin and connector ring exposed surfaces.An energy dispersive spectrometry analysis was performed on a sample of the deposits observed on the pin.The analysis showed the presence of elements present in stainless steel 316.The higher percentage of iron in this sample suggests oxidation may have occurred.Though it is difficult to state conclusively the observed condition of the connector pin mentioned above may confirm this to be a contributing factor for the reported ¿high impedance¿ allegation.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 portion.Internal investigation determined that in the event that the lead becomes compromised through wear or trauma (e.G.An abraded opening in the lead¿s silicone tubing), a charge imbalance may form at this location as a result of the alternate current pathway associated with the original model 105 generator design (e.G.Sn<20000).As a result of this charge imbalance and the low pitting potential of quadfilar coil, coil corrosion can occur resulting in a lead discontinuity.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8078971
• MDR Text Key: 127618753
• Report Number: 1644487-2018-02072
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• 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: Other
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2015
• Device Model Number: 303-20
• Device Lot Number: 2940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Event Location: Other
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2011
• 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: 21 YR