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

Model Number 302-20

Device Problems Fracture (1260); Device Contamination with Body Fluid (2317)

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

Event Date 10/08/2019

Event Type  malfunction  

Event Description

It was reported that during a prophylactic battery replacement for the patient, a lead fracture was found in the lead and therefore the lead was also replaced.Information was received that the surgeon saw the lead break when the leads were taken out.Products have been sent to livanova for analysis and received however product analysis has not been completed to date.No additional relevant information has been received to date.

Event Description

Generator analysis was approved and reviewed.The generator was replaced and returned due to prophylactic reason.The device performed according to functional specifications and analysis of the generator in product analysis (pa) lab concluded that there were no abnormal performance or any other type of adverse condition existing for the generator.The pa worksheet was reviewed and no anomalies were found.Lead analysis was approved and reviewed.Lead was explanted and returned due to fracture of leads however this was not confirmed in pa lab.During visual analysis, abraded openings were observed on the outer and inner silicone tubes.The quadfilar coils appeared to be exposed in this area.With the exception of the abraded openings observed on the outer and inner silicone tubes, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other anomalies were noted.Setscrew marks found on the lead connector pin provide evidence that at one point in time, a good mechanical and electrical connection were present.Continuity checks of the lead were performed and no discontinuities were observed in the returned parts of the lead.Based on the findings in pa lab, there is evidence to suggest inner tubing abraded openings in the returned part of the device with the cause of wear, however there was no evidence to suggest any fracture of leads.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No additional 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
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9253912
• MDR Text Key: 166178608
• Report Number: 1644487-2019-02111
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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: 06/20/2009
• Device Model Number: 302-20
• Device Lot Number: 200265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2006
• 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: 47 YR