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

Model Number 302-30

Device Problems High impedance (1291); Device Contamination with Body Fluid (2317); Appropriate Term/Code Not Available (3191)

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

Event Date 11/06/2019

Event Type  malfunction  

Event Description

It was reported that during a follow up appointment, the patient's generator showed high lead impedance.The patient underwent x-rays to assess the vns system; however, the x-rays have not been reviewed by the manufacturer to date.The patient has been referred for a vns revision.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

Lead product analysis was completed.It was confirmed that there were two discontinuities in the returned lead portion, which is believed to be the cause of the high impedance.Pitting of the lead coil surface at the discontinuities was seen, and abraded openings in the inner and outer silicone tubing were found.The dried remnants of what appeared to have once been body fluids were found inside the outer tubing.All other conditions of the lead were consistent with normal wear and explant procedure.No analysis was possible for the portion of the lead, including the electrodes, that was not returned for analysis.No additional relevant information has been received to date.

Event Description

The patient's lead revision due to high impedance was completed.The patient reported that he is a martial arts instructor and takes impact to the vns area and falls often.The patient was advised that this area should be shielded to prevent damage to the vns device.The explanted lead has been received for analysis and is pending completion of the device evaluation.No additional relevant information has been received to date.

Event Description

X-rays were reviewed by the manufacturer.The connector pin of the lead appeared to be fully inserted inside the connector block.The feedthrough wires appeared to be intact.A portion of the lead was routed behind the generator.No apparent sharp angles or gross fractures were observed in the visible lead portions.The lead wires appeared to be intact at the connector pins.Based on the x-rays received, the cause for the high impedance could not be determined.It was noted that the presence of a fracture or discontinuity in the portion of the lead that is not visible could not be ruled out.No additional relevant information has been received to date.No known surgical intervention has occurred 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: 9371203
• MDR Text Key: 168606979
• Report Number: 1644487-2019-02298
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/15/2009
• Device Model Number: 302-30
• Device Lot Number: 200258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2006
• 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: 39 YR