MAUDE Adverse Event Report: UNKNOWN PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 184

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the non-medtronic rv defib lead had retracted from the set screws in the defibrillator header.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17532739
• MDR Text Key: 321198110
• Report Number: MW5139646
• 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: 07/01/2021

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: 184
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1