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

Device Problem High impedance (1291)

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

Event Date 12/17/2019

Event Type  malfunction  

Event Description

It was reported that the patient had high lead impedance.However, 2 further diagnostics were performed that day and the impedance returned ok.Then, approximately 1 month later, the patient was found to have high impedance again.No adverse events were reported related to the high impedance.No known surgical intervention has occurred to date.No additional relevant information has occurred to date.

Event Description

X-ray images were received and reviewed.The connector pin of the lead appeared to be fully inserted inside the connector block.The feedthrough wires appeared to be intact.A portion of the lead was routed behind the generator.No apparent sharp angles or gross fractures were observed in the part of the lead visible in the x-ray images provided.The lead wires appeared to be intact at the connector pin.Based on the x-rays received, the cause for the high impedance could not be determined.Note that the presence of a microfracture or a discontinuity in the portions of the lead that were not visible cannot be eliminated at this time.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

Clinic notes were received indicating that shortly after generator replacement, at the time that high impedance was identified, there was a lack of efficacy with the newly implanted device.The lack of efficacy can be attributed to the temporary interruption in therapy, as the patient's previous generator battery had depleted, and the patient's settings had to be re-titrated to the prior therapeutic settings.As the settings were increased, the patient's depression improved.However, it is also possible that the efficacy was adversely impacted by the high impedance.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9672199
• MDR Text Key: 184258726
• Report Number: 1644487-2020-00184
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 08/11/2020

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 03/05/2020; 07/17/2020
• Supplement Dates FDA Received: 03/13/2020; 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR