MAUDE Adverse Event Report: BIOTRONIK LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number S60

Device Problems Over-Sensing (1438); Impedance Problem (2950); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

Rv lead alert/polarity switch first occurred on (b(6) 2023.Patient in clinic on (b)(6) 2023 with normal lead function.She states they assess for oversensing with isometrics and none was noted.Positional impedance values were not done.She states programmed back to bipolar and there was another polarity switch on (b)(6) 2023.Reviewed remote transmissions and per trending the low impedance values have occurred both unipolar and bipolar.Reviewed further and there is a vt-ns oversensing episode noted on (b)(6) 2023 prior to programming session.Short circuit paces seem to be sudden onset and are continuing to increment.Recommended caller contact biotronik for questions regarding the lead, but per transmissions this is the beginning of a lead integrity issue and the lead can't be relied on.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17489816
• MDR Text Key: 320712803
• Report Number: MW5122334
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2023

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?: No
• Device Model Number: S60
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1