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

Model Number 302-20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 07/11/2019

Event Type  malfunction  

Event Description

Patient underwent defibrillation and reported experiencing a chocking sensation and painful stimulation/shocking following the event.Per the patient's neurology office, the lead wire was fried.The device was disabled.It was noted that the cardioversion had burned the vns wire and that the patient was referred for device replacement.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

Corrected data, initial report: lot # inadvertently not included.Corrected data, initial report: device manufacture date inadvertently not included.

• 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: 8885889
• MDR Text Key: 154126986
• Report Number: 1644487-2019-01559
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/06/2004
• Device Model Number: 302-20
• Device Lot Number: 6267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2002
• 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: 64 YR