MAUDE Adverse Event Report: UNKNOWN LINOX; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number LINOXTD

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

Rv bipolar oor measure on (b)(6) 2020.He rv bipolar oor is not a new finding and originally ocrurred on (b)(6) 2020.Device has been programmed tip to coil since 2016 following rv lia triggered (b)(6) 2016.No short v-v intervals since (b)(6) 2020.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LINOX
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535247
• MDR Text Key: 321186946
• Report Number: MW5142146
• 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: 12/01/2020

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: LINOXTD
• Patient Sequence Number: 1