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 Problem Arrhythmia (1721)

Event Date 11/01/2018

Event Type  Injury  

Event Description

It was reported that the patient was implanted with vns to treat depression, and that the patient experienced a cardiac arrest at the end of a surgery in november 2018.Per the reporter, the patient¿s battery has been dead for some amount of years.There was no indication the surgery was associated with vns; however, a concern was expressed that the cardiac arrest may be associated with the lead remaining attached to the vagus nerve.No additional or relevant information has been received to date.

Event Description

Further follow up with the anesthesiologist confirmed that the vns device was recently ruled out as a possible contributor to the cardiac event, as it was confirmed to be "non-functional," which was defined as the generator battery being completely depleted.It was further confirmed that the vagus nerve was not manipulated during the procedure, and that the patient has no evidence of cardiac disease.It was mentioned that the patient will have the occasional unifocal pvc and fainting spells attributed to "vasovagal syndrome." additionally, it was noted that the patient does have a history of possible cataplexy but was never medicated for it.No other relevant information has been received 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: 8556175
• MDR Text Key: 143271805
• Report Number: 1644487-2019-00802
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 06/29/2019

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: 06/17/2006
• Device Model Number: 302-20
• Device Lot Number: 010763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 13 YR
• Event Location: Other
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 06/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2004
• 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: 51 YR