MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem Fracture (1260)

Patient Problems Scarring (2061); Neck Pain (2433); No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

Patient presented with high lead impedance on system diagnostic tests.Patient reported that they had fallen one month before the high impedance was seen.The physician programmed the patients output current to 0ma.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Information was received noting that patient had their generator replaced.During the surgery, the old generator was removed and re-inserted into the pin.System diagnostics were then taken and indicated ok impedance.The diagnostics were taken several times and no anomalies were noted.The surgeon tugged on the lead to ensure no anomalies with the lead, and system diagnostics again showed no anomalies.During the initial removal of the old generator, surgeon mentioned that the lead was placed both above and below the generator and there was a kink in the lead.However the lead was encapsulated inside the pocket and so was difficult pulling out the kinked part to examine.It was speculated that this kink may be the cause of the high impedance.Multiple diagnostics was performed to try to capture another high impedance but was unsuccessful.At this time, the surgeon elected to get a new generator to replace the old one.The new generator was tested and no anomalies were seen, and then the patient was closed.The patient was tested still in the or while closed, and had high impedance.Then, the patient was tested three more times with results all ok.In the recovery room, the patient was tested again and showed high lead impedance on two system diagnostics tests.The explanted generator has not been returned to the manufacturer to date.

Event Description

Further information was received noting that the patient had their device programmed off a few months prior and had a planned full replacement (generator and lead).During the surgery, the surgeon noted that there was extensive scarring around the electrodes of the original lead.Multiple diagnostic tests were performed, with the patient's body in different orientations, and high lead impedance was not seen.The patients impedance was fine and battery was at depleted.The physician used an accessory pack to check the lead it came back fine with good impedance.The surgeon decided to close the patient and did not explant the generator or lead.Additional information was received noting that the patient presented to the physicians office following the surgery and the high lead impedance was resolved.The patients device was interrogated and the device showed disabled due to end of service, the device was then programmed to 1ma.Diagnostics were then ran and battery status and impedance were both noted to be ok.No other relevant information has been received to date.

Event Description

Patient again presented with high lead impedance and neck pain.Patients device was disabled.

Event Description

Clinic notes were received indicating that the patient had chest x-rays performed on (b)(6) 2019 and did not show any lead damage.The x-rays have not been reviewed by the manufacturer to date.

Event Description

Patient presented with high lead impedance and pain at lead site.Patient had their device programmed off.Additional information was received from the rep noting that the excessive scarring was referring to the scarring around the vagus nerve.Since the initial lead implant, there was been a significant amount of scar tissue built up around the lead electrodes and nerve.The physician noted that the scar tissues surrounding the nerve was more significant than most she had seen in the past.There was no intervention taken or planned regarding the excessive scar tissue around the nerve.The surgeon tried to move through it and thought it was too unsafe to continue.

Manufacturer Narrative

B5.Corrected information, supplemental report 02: "patient presented with high lead impedance and pain at lead site.Patient had their device programmed off." inadvertently not included.F10.Corrected information, supplemental report 02: code 2433 inadvertently not included.

Event Description

The patient's generator and lead were replaced.The explanted products have not been received by the manufacturer to date.No other relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9012545
• MDR Text Key: 158173553
• Report Number: 1644487-2019-01766
• 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,Followup,Followup
• Report Date: 11/22/2020

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: 08/14/2003
• Device Model Number: 300-20
• Device Lot Number: 3821
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 01/22/2020; 05/29/2020; 06/23/2020; 07/17/2020; 08/26/2020; 11/03/2020
• Supplement Dates FDA Received: 02/14/2020; 06/23/2020; 07/17/2020; 08/11/2020; 09/18/2020; 11/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR