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

Model Number 302-20

Device Problems Low impedance (2285); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2016

Event Type  malfunction  

Event Description

Clinic notes were received on (b)(6) 2016 and dated (b)(6) 2016.It was stated there was a warning message that there was low impedance < 600 ohms.The patient denies any unusual stimulation or shock-like sensations.The device was interrogated again on (b)(6) 2016 and it was stated impedances were fine.No surgical intervention has occurred to date.No additional information has been received to date.

Event Description

The patient was seen again in the physician's office, and the diagnostics showed that impedance was within normal limits.The patient refused surgery at that time because the impedance was within normal limits, even though low impedance was seen at a previous office visit.No surgical intervention has occurred to date.

Event Description

An implant card was later received reporting that the patient had a full revision due to the low impedance.Impedance values were within normal limits with the new devices.The explanted suspect device (lead) is not available for return to the manufacturer.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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 6178919
• MDR Text Key: 62849676
• Report Number: 1644487-2016-02882
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2009
• Device Model Number: 302-20
• Device Lot Number: 1598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2006
• 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: 45 YR
• Patient Sex: Female