MAUDE Adverse Event Report: BIOTRONIK PLEXA PROMRI DF-1 S DX 65/15; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number PLEXA PRO

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

It was reported that the lead was surgically abandoned due to an unknown product performance issue.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PLEXA PROMRI DF-1 S DX 65/15
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17536746
• MDR Text Key: 321165396
• Report Number: MW5143630
• 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

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: PLEXA PRO
• Patient Sequence Number: 1