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

Model Number 302-20

Device Problems Fracture (1260); Low impedance (2285)

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

Event Date 01/09/2021

Event Type  malfunction  

Event Description

The patient's generator was interrogated and high impedance/low output status were reported.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No additional relevant information has been received.

Event Description

It was reported that the neurologist requested the patient come back to the clinic; however, no response has been received to date.It was noted that the neurologist is not overly concerned and is not going to push the issue as the patient continues to do well.No intervention is planned at this time.No additional relevant information has been received to date.

Event Description

It was reported that the patient was seen recently and low impedance (<600 ohms) was observed.Per the provider, the patient continues to do well so no intervention is planned.No known surgery has occurred to date.No additional relevant information has been received.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11286021
• MDR Text Key: 234546040
• Report Number: 1644487-2021-00182
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/25/2008
• Device Model Number: 302-20
• Device Lot Number: 1368
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/05/2021; 07/13/2021
• Supplement Dates FDA Received: 03/02/2021; 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR