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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

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

Event Date 05/24/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was detected during a patient's generator replacement surgery, planned due to battery depletion.As the generator's battery was completely depleted, preoperative diagnostics could not be performed.After the generator was replaced, high impedance was detected on the new generator.Pin reinsertion did not resolve the high impedance.The lead was not replaced and the new generator was left disabled.The generator was received and underwent product analysis.Product analysis on the returned generator verified that it was at end of service and unable to communicate due to normal, expected battery depletion.The generator performed according to specifications with no abnormal performance or any other type of adverse condition found no further relevant intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient's lead and generator were replaced due to high impedance.No further relevant information has been received to date.The suspect product has not been received to date.

Event Description

The explanted lead and generator were returned for analysis.Product analysis was completed on the returned m106 various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive electrical evaluation showed that the device performed according to functional specifications.No anomalies were identified.Product analysis on the lead has not been completed to date.

Event Description

Product analysis was completed on the returned lead.The lead assembly was returned in 5 portions.Portions of the positive and negative silicone tubes and wire coils as well as tie-downs were not received and therefore an evaluation and resulting commentary could not be made on those portions of the lead.Visual analysis identified 1 abraded opening in the outer tubing, and an abraded opening in both the inner and outer tubing where both the positive and negative coils were exposed.These abraded openings, along with the cut ends /puncture marks made during surgery, most likely provided the leakage path for the dried bodily fluids identified in the outer and inner silicon tubing.A lead break in both the negative and positive quadfilar wires in one location was identified.Scanning electron microscopy of the lead breaks showed extensive pitting and evidence of a stress induced fracture.It is believed that stimulation was present for a certain period of time after the lead break as evidenced by the presence of metal pitting.Setscrew marks were observed on the lead pin which provide evidence that, at one point in time, a good electromechanical connection between the lead and generator was present.Continuity checks identified no other discontinuities with the exception of the coil breaks and abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.

• 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: 7824043
• MDR Text Key: 118529977
• Report Number: 1644487-2018-01509
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/02/2009
• Device Model Number: 302-20
• Device Lot Number: 1501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2006
• 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: 41 YR