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

Model Number 302-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Scarring (2061); Tissue Damage (2104); Fibrosis (3167)

Event Date 09/08/2003

Event Type  Injury  

Event Description

It was reported that the surgeon had difficulty replacing the patient's lead during a revision due to the lead being improperly placed and the presence of scarring, carotid artery damage, and damage to the nerve.The surgeon indicated that these events occurred as a result of the patient's initial implant surgery.The patient's lead revision due to high impedance captured in mfr.Report # 1644487-2016-02440.Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

Manufacturer Narrative

(b)(4).

• 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: 8902424
• MDR Text Key: 154587317
• Report Number: 1644487-2019-01522
• 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: 09/05/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/22/2005
• Device Model Number: 302-20
• Device Lot Number: 8814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2003
• 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): Other
• Patient Age: 44 YR