MAUDE Adverse Event Report: UNKNOWN RV LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 359065

Device Problems Impedance Problem (2950); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2021

Event Type  malfunction  

Event Description

Rv lead integrity warning on (b)(6) 2021.Rv lead impedance warning on (b)(6) 2021.Rv lead integrity warning on (b)(6) 2021.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524485
• MDR Text Key: 321444746
• Report Number: MW5131431
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 359065
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1