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

Model Number 303-20

Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317)

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

Event Date 06/06/2018

Event Type  malfunction  

Event Description

It was reported that high lead impedance was observed which was caused by a fall (not seizure related) which knocked the patient's generator.It was stated that it appears from looking at a scan that the pin has come away from the generator.The patient underwent full revision surgery, and the explanted products have not been received by the manufacturer to date.No other relevant information has been received to date.

Event Description

Additional information was received from the doctor stating that the internal wiring of the lead and the connection to the battery were damaged which was a contributing factor to the patient¿s full revision.The explanted generator and lead were received for product analysis.The lead underwent product analysis where the lead wire was observed to be fractured.Corrosion was observed at the point of fracture.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.The abraded openings were found on the bilumen tubing which likely provided the leakage path for dried remnants of what appeared to have once been body fluids.Based on the findings, there is evidence to suggest a discontinuity in the returned portions of the device.No other obvious anomalies were noted.The generator underwent product analysis and various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.The pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Information from the generator memory indicated high impedance first occurred on (b)(4) 2018.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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7645739
• MDR Text Key: 112721471
• Report Number: 1644487-2018-01086
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/23/2019
• Device Model Number: 303-20
• Device Lot Number: 300372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2015
• 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: 9 YR