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

Model Number 302-20

Device Problems Low impedance (2285); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/03/2020

Event Type  malfunction  

Event Description

The patient was referred for surgery or an office visit with the surgeon due to their vns "not working." no other relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

Low impedance was seen on the patient's device and was stated to be what was meant by the phrase "not working." it was noted that when the device was last checked, the impedance was about 3000 ohms.There were no increased seizures or discomfort.No trauma was noted to have occurred.The doctor did not have an assessment on the cause of the low impedance but did not think it was of concern.No known surgical intervention has occurred to date.No other relevant information has 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: 10593906
• MDR Text Key: 208791053
• Report Number: 1644487-2020-01307
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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
• Report Date: 10/23/2020

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: 01/06/2005
• Device Model Number: 302-20
• Device Lot Number: 7596
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR