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

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 02/10/2020

Event Type  malfunction  

Event Description

Patient presented with high lead impedance and low output current.It was also noted that the patient had a lack of efficacy with the device that started at the same time as the high lead impedance.The physician's office does not know the reason for the high lead impedance, or if there was a gradual increase in impedance.The patient later reported that she was attacked by a dog prior to the high impedance reading.The patients device was later interrogated and system diagnostics showed high lead impedance and low output current.The patients output current was reduced and system diagnostics were again run.The output current was ok; however, high lead impedance was again seen.Ap and lateral chest and neck x-ray images were received.The generator was located in the upper left chest.Due to the angle and quality of the image, it cannot be assessed if the connector pin is fully past the second connector block or if the filter feedthru wires were intact.The lead was visualized in the chest and neck.The lead appears to be routed behind the generator.The lead wires appear to be intact at the connector pin.No sharp angles were observed in the lead.The lead was assessed for fractures and no gross fractures or discontinuities were noted.Based on the x-rays received, the cause for the high impedance cannot be determined at this time.Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images.No known relevant surgical intervention has occurred to date.No additional or relevant information has been received to date.

Event Description

Patient had lead revision surgery.Following the patients lead replacement, the patients lead impedance was noted to be ok.The explanted lead was noted to have been discarded following the surgery.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: 9793811
• MDR Text Key: 186786365
• Report Number: 1644487-2020-00384
• 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
• Report Date: 06/30/2020

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: 11/28/2009
• Device Model Number: 302-20
• Device Lot Number: 1766
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR