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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Nerve Damage (1979); No Known Impact Or Consequence To Patient (2692); Fibrosis (3167)

Event Date 07/23/2019

Event Type  malfunction  

Event Description

Patient presented with low battery and high lead impedance and was referred for full revision (replacement of the lead and generator).Patient presented for surgery.Impedance was high and the generator was replaced.Impedance was high with the replacement generator.Pin re-insertion was performed and the high impedance resolved therefore the patient was closed.Impedance was checked in post operation and the lead impedance was high again.The patient was referred back for lead revision.No further surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Further information was received that the explanted lead and generator were discarded.

Event Description

Patient underwent lead revision surgery.The explanted lead has not been received by product analysis to date.

Event Description

Further information was received that during the lead revision surgery, the neurosurgeon noted that the vagus nerve was impaired and had trouble implanting the new lead.

Event Description

Additional information received noting that the patient is being referred for re-implant and may require a right-sided implant due to the presence of scar tissue.

• 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: 8898067
• MDR Text Key: 154460604
• Report Number: 1644487-2019-01581
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2011
• Device Model Number: 302-20
• Device Lot Number: 200799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2008
• 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: 73 YR
• Patient Sex: Male