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

Model Number 304-20

Device Problem Detachment of Device or device Component

Event Date 01/06/2019

Event Type  Malfunction  

Event Description

It was reported that high lead impedance was found while the patient was in the clinic and suspected to be a lead break. Output current was stated to be low. Patient had consult with surgeon and scheduled lead revision surgery. Information was received confirming the revision surgery took place. It was stated that during the replacement case, the lead pin was found in the generator cavity and the silicone portion of the lead was detached from the lead pin. Surgeon located the generator and found that it was not attached to the lead. Both the generator and lead were replaced. It was stated both the generator and lead would be sent back for analysis, but has not been received to date. It was stated that the wires were not abraded and was a clean detachment from the pin. It was also stated that there was no known trauma to the area and physician does not know what could have caused this. No additional 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: 8658057
• Report Number: 1644487-2019-01026
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/01/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/31/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 11/11/2016
• Device MODEL Number: 304-20
• Device LOT Number: 202308
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Other
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 11/15/2012
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial