MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

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

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

Event Date 06/04/2018

Event Type  malfunction  

Event Description

It was noted at the generator replacement surgery that high impedance was also found and a lead revision surgery was performed as a result.Troubleshooting steps during the surgery were offered to the surgeon, however the surgeon declined troubleshooting and decided to replace the lead prophylactically as it was believed that the new leads "were better made and the old leads are flimsy".It was further confirmed that the impedance was within normal limits pre-operatively.The devices were shipped back for analysis, however no devices were received to date.No additional relevant information has been received to date.

Event Description

The explanted devices were returned for analysis.Analysis of the generator was performed and found no anomalies.The device performed according to functional specifications.Review of the device's internal data noted an impedance change from impedance within normal limits to high impedance detected to have occurred on the date of explant.No other anomalies were noted.The lead assembly was returned in one portion.It is noted that a portion of the lead assembly including the electrodes and tie downs was not returned.Setscrew marks were observed on the connector pin, providing evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin.Abraded openings were noted of the inner and outer silicone tubing.Continuity checks of the returned lead portion were performed, and no discontinuities were noted in the portion of the lead returned, and therefore could not confirm a fracture.No other anomalies were noted.No additional relevant information was received to date.

Event Description

Tablet data was received providing further programming history from the patient's pre-replacement and post-replacement devices.Programming history was reviewed for the patient's previous device and noted that the last diagnostics observed were from 2012 indicating that the device was functioning as intended with no apparent malfunctions.Programming history was reviewed for the patient's replacement device and noted that high impedance was observed upon first interrogation and system diagnostic.Subsequent diagnostics performed about two hours after the high impedance was seen indicated that the device was functioning within normal limits.No further information was received to date.

• Brand Name: LEAD MODEL 302
• 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: 7990838
• MDR Text Key: 124560589
• Report Number: 1644487-2018-01883
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2005
• 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: 15 YR