MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

Device Problems Mechanical Problem (1384); Low impedance (2285)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2019

Event Type  malfunction  

Event Description

The surgeon reported a lead issue observed during a full vns implant surgery.It was reported that the lead coils were damaged, and that the damage was present out of the box.It was noted that a lead impedance test was performed and registered low lead impedance.A test resistor was used to confirm normal functioning of the generator.The surgeon opted to open a new lead for implant.The suspect product is to be returned to the manufacturer for analysis.A review of device history records for the lead confirmed that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.Further follow up with the implanting facility confirmed that there was no observable damage to the lead packaging, and that the lead was stored in an appropriate and controlled environment.The suspect product has not been received to date.No other relevant information has been received to date.

Event Description

The lead was returned for product analysis.An analysis was performed on the returned lead portion, and low impedance and damaged/kinked coil conditions were confirmed.The lead was returned intact.During the visual analysis the front portion of the connector ring appeared to be crushed.The rear end of the small front o-ring appeared to be torn with what appeared to be remnants of dried body fluids inside the torn areas.Tool marks were observed on the connector ring surface in the vicinity of the small front o-ring.It is unknown what caused the observed damage.X-rays were taken of the crushed area observed on the front portion of the connector ring.The x-rays indicated the connector pin and connector ring appeared to be touching.A resistance measurement was performed between the connector pin and connector ring and verified there was an electrical short.The measurement was 0.7 ohms.Per the manufacturing procedure, the lead is acceptable provided that the resistance is greater than 1 m ohm.With the exception of the crushed connector ring area and unintended electrical short circuit, the condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure.During the visual analysis the white (+) and green (-) electrode ribbons appeared to be stretched and the helices misshaped.These findings indicate an attempted use of this lead assembly.No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator.The additional 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 assembly were performed with no discontinuities identified.Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications.Based on the findings in the product analysis lab, there is no evidence to suggest any device-related anomaly with the returned lead.The confirmed mechanical damage to the connector region, resulting a crushed connector ring assembly onto the pin assembly and creating an unintended electrical short between the two normally isolated conductors; was likely caused during surgical procedure.No other anomalies were present.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8947215
• MDR Text Key: 156099411
• Report Number: 1644487-2019-01695
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

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: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: 303-20
• Device Lot Number: 204510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• 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