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

Model Number 302-20

Device Problems Fracture (1260); Mechanical Problem (1384)

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

Event Date 10/16/2018

Event Type  malfunction  

Event Description

It was reported that during surgery, after a m102 generator was replaced due to battery depletion, high impedance was detected on the replacement 106 generator.System diagnostics on the m102 generator prior to surgery indicated that impedance was ok.Intraoperative diagnostics performed on the m106 after the initial lead connection was ok.However, after the surgeon placed the 106 in the pocket and closed it, another diagnostic recorded high impedance ohms with only 0.5ma current delivered.Repeated diagnostics showed high impedance with differing low output currents.The surgeon then removed the generator from the chest and the pin was reinserted.Pin reinsertion was attempted twice more; however, diagnostics were still high.While performing the pin reinsertion, it was also visually confirmed that the lead pin was past the connector block and then it was confirmed that the setscrew was tightened until it clicked, but impedance did not resolve.Therefore, the lead was replaced, and the high impedance resolved.It was also reported that there was two places where the lead visually looked "abraded".The suspect product has not been received to date.No further relevant information has been received to date.

Event Description

The associated generator was received for analysis.Analysis on the generator has not been completed to date.The suspect product (lead) has not been received to date.

Event Description

Product analysis was completed on the returned generator.The generator was at end of service condition.The generator performed according to functional specifications, per the post-burn electrical test, with no anomalies identified.No further relevant information has been received to date.The suspect product has not 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8057524
• MDR Text Key: 127069619
• Report Number: 1644487-2018-02015
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2010
• Device Model Number: 302-20
• Device Lot Number: 200487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2007
• 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 Age: 39 YR