MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 300

Model Number 300-20

Device Problems High impedance (1291); Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

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

Event Date 11/15/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was detected on a newly implanted generator during a replacement surgery, planned due to battery depletion.The now explanted generator was interrogated prior to the replacement surgery and the impedance value from the last 24-hour check showed impedance within normal limits.Generator diagnostics using a test resistor pin with the new replacement generator were within normal limits.No dual pin leads were available at the facility during the replacement surgery and therefore the surgeon chose to implant a new lead and generator following the high impedance.Lead impedance resolved after the lead and generator were replaced.The suspect product was received but analysis on the device has not been received to date.No further relevant information has been received to date.

Event Description

Product analysis was completed for the returned generators and on the returned lead.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present between the lead and a generator.Product analysis observed an abraded opening in the outer and inner lead tubing that exposed the conductive coil.An additional abraded opening in only the outer tubing was also identified.The lead assembly had dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion no other anomalies were identified.Product analysis was completed on the explanted generator that was returned due to near end of service battery depletion.The generator performed as expected with no failures identified.Per the internal data of the device, there was no evidence of high impedance, indicating that the high impedance occurred after the battery became depleted or after generator replacement occurred.Product analysis was completed on the generator that was opened but not used, due to lead compatibility, and there were no performance or any other type of adverse conditions found with the pulse generator.High impedance was detected on the generator on the day the generator was opened but not used as expected.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 300
• 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: 8136236
• MDR Text Key: 129480732
• Report Number: 1644487-2018-02213
• 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
• Report Date: 01/16/2019

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: Lay User/Patient
• Device Expiration Date: 09/30/2001
• Device Model Number: 300-20
• Device Lot Number: 28665C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/1999
• 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: 32 YR