MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-30

Device Problem Fracture (1260)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 09/16/2017

Event Type  malfunction  

Event Description

Report received that a patient's vns was interrogated and high impedance was observed.The patient reported that he stopped feeling stimulation four months prior to this observation.It was reported that trauma was not suspected to have contributed to the high impedance.No surgical interventions have occurred to date.No further relevant information has been received.

Event Description

It was reported that the patient was feeling a shocking sensation in his chest, so the physician programmed the device off.No surgery has occurred to date.

Event Description

Patient underwent generator replacement surgery.The explanted generator has not been received by the manufacturer to date.The patient also reported that he has been tazed repeatedly with a 50,000 watt tazer and due to excessive force he felt his generator break.No known surgical intervention has occurred with the suspect product (lead) to date.No other relevant information has been received to date.

Event Description

Explanted generator was received by the manufacturer.Product analysis completed on the returned generator.The electrical tests performed in the pa lab found that the generator was at an ifi = no condition.The battery voltage was measured at 2.915 volts, and the memory locations on the generator indicated that 56.995% of the battery had been consumed.The generator underwent 24 hour monitoring in a simulated body temperature environment.There were no variations in the output signal, the device supplied the expected level of output current during the entire period and diagnostics were as expected.The magnet activations performed confirmed that the appropriate magnet output for the programmed settings.There were no performance or any other type of adverse conditions found with the pulse generator, and the pulse generator performed according to functional specifications.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• 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: 7261480
• MDR Text Key: 99954315
• Report Number: 1644487-2018-00194
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/10/2018
• Device Model Number: 304-30
• Device Lot Number: 202921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2014
• 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: 34 YR