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

Model Number 302-20

Device Problem Detachment Of Device Component (1104)

Patient Problem Nerve Damage (1979)

Event Date 08/21/2010

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was undergoing generator replacement surgery when the surgeon identified abraded openings in the lead tubing (reported in mfr.Report #1644487-2018-00663), so a lead revision was then performed.It was then identified that there was no strain relief, and the electrodes were detached from the nerve.The surgeon and ear, nose, and throat specialist stated that the nerve was bubbled and severely scarred from the electrodes rubbing on it.The impedance was within normal limits prior to the surgery, which indicated that the electrodes were in contact with patient tissue while implanted.It was believed that the electrodes rubbed against the nerve after becoming detached, which caused the damage to the nerve.The lead was received by the manufacturer, and analysis was performed (reported in mfr.Report #1644487-2018-00663).However, the electrode portion of the lead was not returned, so no analysis could be performed on the portion of the lead relevant to this report.No further relevant information has been received to date.

Event Description

The device history record for the lead and showed that the lead passed all quality specifications and functional requirements prior to distribution into the field.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7467612
• MDR Text Key: 106863382
• Report Number: 1644487-2018-00664
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2014
• Device Model Number: 302-20
• Device Lot Number: 2658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2010
• 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 Outcome(s): Required Intervention
• Patient Age: 9 YR