MAUDE Adverse Event Report: BOSTON SCIENTIFIC ATRIAL LEADS; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 4135, 4136

Device Problems Under-Sensing (1661); Impedance Problem (2950); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Atrial bipolar lead impedance warning.Noted atrial undersensing on episode egm that could affect mode switch operation, atrial pacing, and detection/termination of at/af episodes.Low measured p-waves.Low measured r-waves.Leads manufactured by boston scientific.Case: (b)(4) / (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ATRIAL LEADS
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17536303
• MDR Text Key: 321356915
• Report Number: MW5143192
• 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: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4135, 4136
• Patient Sequence Number: 1