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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260)

Patient Problems Anxiety (2328); Depression (2361); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2022

Event Type  malfunction  

Event Description

Patient presented with high lead impedance and underwent x-rays.On chest and neck x-rays the leads appear intact and connected to the pulse generator.The x-ray images were received and reviewed by the manufacturer.The generator placement was determined to be normal in the upper right chest.Based on the images provided, the feedthrough wires were intact, and the connector pin appeared to be fully inserted.The lead was visualized in the chest and neck.It appears that a strain relief loop and bend were attempted but not according to labelling.The loop was placed directly following the electrodes and the bend was not sufficient.There were 3 visualized tie downs present on the lead, none were securing the loop.A portion of the lead was visualized to be routed behind the generator.The lead was assessed for fracture and discontinuities on the visible portions of the lead however none were noted.Based on the x-rays received, the cause of the high impedance cannot be confirmed; however, any fractures or microfractures on the portions of the lead that were not visible cannot be ruled out.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Clinic notes received noting that the patient (b)(6) depression worsened after their device was turned off on (b)(6) 2029 and also increased anxiety.The patient (b)(6) s device was programmed back on 5/2 and they have been referred for surgery to undergo a revision due to the high impedance.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

B1 adverse event or product problem, corrected data: initial report inadvertently forgot to also select adverse event b5 describe event or problem, corrected data: initial report inadvertently left out relevant information b6 relevant tests/laboratory data, including dates, corrected data: initial report inadvertently left out relevant information f10 adverse event problem, corrected data: initial report inadvertently left out code 'e020201' and 'e020202'.

Event Description

Patient underwent full revision surgery.The explanted products have not been received by product analysis to date.

Manufacturer Narrative

B5 describe event or problem, corrected data: supplemental #02 report inadvertently left out relevant information from the pathology report.

Event Description

Additional information received noting that per the pathology report the lead came out in pieces and one end of the lead wire was flattened.It was also reported that during the explant surgery the surgeon had to manipulate the patient's nerve more than he normally would.The explanted generator and lead were received but product analysis is still underway.

Event Description

Product analysis was completed on the returned generator and lead.An interrogation and system diagnostic tests were performed.The device output signal was monitored for more than 24-hrs and a comprehensive automated electrical evaluation (shows an ifi=no condition) was performed.No anomalies were seen, and the device performed according to functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.During the visual analysis of the second portion, coil2 was found to be broken.The broken ends of the coil appeared dark and showed signs of pitting.Due to the pitting, the fracture mechanism could not be ascertained.Continuity checks of the returned lead portions were performed during the functional analysis, and no other discontinuities were identified.One half set of setscrew marks were found near the end tip of the connector pin, indicating the lead connector had not been fully inserted into the cavity of the pulse generator at one time.The location of the two full setscrew marks found on the lead connector pin provide evidence that the lead connector pin was inserted completely, and a good mechanical and electrical connection was present at least twice.Canted spring scratches were observed on the connector ring surface.No anomalies preventing the connector pin from being fully inserted into the generator were noted.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.

Event Description

The lead was visualized in the chest and neck.The lead was visualized to be implanted upside down.Reverse polarity of the electrodes (positive electrode is placed cranial, negative electrode is placed caudal) can cause the therapy to be delivered away from the brain on the vagus nerve which would not supply adequate therapy.However this would not be expected to cause high impedance.

Manufacturer Narrative

B5 describe event or problem, corrected data: initial report inadvertently did not note that the electrodes were seen to have inverted placement in the x-rays provided.

• 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: 14452607
• MDR Text Key: 292201457
• Report Number: 1644487-2022-00565
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 01/03/2023

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: 10/05/2008
• Device Model Number: 302-20
• Device Lot Number: 1330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/24/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/13/2022; 08/08/2022; 09/13/2022; 10/19/2022; 01/03/2023
• Supplement Dates FDA Received: 06/13/2022; 09/02/2022; 10/04/2022; 10/26/2022; 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2005
• 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: 54 YR
• Patient Sex: Female