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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Pain (1994); Anxiety (2328); No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2020

Event Type  malfunction  

Event Description

It was reported that a patient has high impedance.The patient did not have any reported recent injuries or trauma.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Information was received that the patient's explanted devices were discarded.No additional relevant information has been received to date.

Event Description

Information was received via clinic notes regarding the patient's high impedance.Notes stated that during a visit the patient indicated it was not firing properly.The physician performed an x-ray confirming continuity grossly, however very high impedance is noted on interrogation of the device.It was stated the patient had difficulty tolerating higher dose stimulation with anxiety and apprehension related to throat discomfort but is tolerating the current stimulation output.It was stated stimulation parameters will be maintained.Information was received that the patient's lead and generator were explanted and replaced.The patient's explanted products have not been received into analysis to date.No additional relevant information 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
• MDR Report Key: 9981364
• MDR Text Key: 190126115
• Report Number: 1644487-2020-00625
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/27/2008
• Device Model Number: 302-20
• Device Lot Number: 1501
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 09/01/2020; 10/05/2020
• Supplement Dates FDA Received: 09/25/2020; 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR