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

Model Number 302-20

Device Problems Fracture (1260); Battery Problem (2885)

Patient Problem Depression (2361)

Event Date 01/01/2016

Event Type  malfunction  

Event Description

It was reported that the patient has been experiencing an increase in depression that has progressively worsened over the past few months.The patient's husband thinks the generator battery is depleted.The patient was given a new physician's name; however, it is unknown whether or not the patient has been seen.No additional relevant information has been received to date.

Event Description

During a generator replacement, high impedance was observed once the new generator was connected to the leads.The explanted generator could not be interrogated before surgery due to battery depletion.The lead pin was reinserted and the set screw was sufficiently tightened.An intra-op x-ray was taken and no discontinuities were observed.The explanted generator was discarded.No known surgical intervention has occurred to date with the lead.

Event Description

Patient underwent lead replacement surgery.The explanted lead was removed in many pieces, so it was discarded.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 5541708
• MDR Text Key: 42069324
• Report Number: 1644487-2016-00684
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2010
• Device Model Number: 302-20
• Device Lot Number: 200614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2007
• 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: 52 YR