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

Model Number 302-20

Device Problems Fracture (1260); Mechanical Problem (1384)

Patient Problems Nerve Damage (1979); No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2018

Event Type  malfunction  

Event Description

The patient was in a recent car accident.Vns was checked and diagnostics were reported to be within normal following the accident.However interrogation of the device a couple of months after shows high impedance.The device was disabled at that time.There was no defined lead break based on x-ray review by neurologist.No known surgical interventions have occurred to date.

Event Description

The patient underwent generator and lead revision surgery due to high impedance.The suspect lead has not been received to date.

Event Description

The lead and generator were received.The pulse generator was explanted/returned due to ¿prophylactic replacement¿.The reported allegation of ¿high impedance¿ was not duplicated in the pa lab.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis of the lead is underway but has not been completed to date.

Event Description

It was reported that during a car accident which damaged the patient's previous lead, the seatbelt had pulled the lead down and damaged the patient's nerve.No other relevant information has been received to date.

Event Description

An analysis was performed on the returned lead portions and the electrodes were not returned for analysis.Therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the returned 164mm portion quadfilar coil 1 appeared to be broken.Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break and identified the as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting.Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break and identified the area as having extensive pitting which prevented identification of the coil fracture type with residual material.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.What appeared to be white deposits were observed in various locations.With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The 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 portions were performed, during the visual analysis, and no other discontinuities were identified.

• 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: 7787420
• MDR Text Key: 117292624
• Report Number: 1644487-2018-01408
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750092
• UDI-Public: 05425025750092
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2004
• Device Model Number: 302-20
• Device Lot Number: 7150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2002
• 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: 21 YR