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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2019

Event Type  malfunction  

Event Description

The patient underwent full revision surgery due to battery depletion and high impedance.The sales representative present at surgery informed that the high lead impedance was discovered during an appointment with the patient's neurologist.The sales representative noted that they first switched out the generator to see if the high impedance resolved.The lead showed to have high impedance after the generator was replaced, so the lead was replaced as well.Further follow up with the neurologist confirmed that the reason for high lead impedance is unknown.The neurologist noted that in the operating room, the lead did not appear to be fractured.The sales representative received the explanted generator for return.The explanted product has not been received to date.No other relevant information has been received to date.

Event Description

The explanted generator was the only product returned for product analysis.The explanting facility is typically a no return and discards explanted product.Therefore, the explanted lead is not expected to be returned.Generator analysis was performed, and a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Review of the lead impedance history stored on the patient's generator confirmed that the first high impedance reading was captured on (b)(6) 2019.Product analysis concluded that there were no performance or any other type of adverse conditions found with the pulse generator.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: 8530162
• MDR Text Key: 142479621
• Report Number: 1644487-2019-00749
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/12/2019
• Device Model Number: 304-20
• Device Lot Number: 203318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 06/06/2019
• Supplement Dates FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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 Age: 10 YR