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

Model Number 7121

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

Patient Problem Insufficient Information (4580)

Event Date 06/22/2021

Event Type  malfunction  

Event Description

No ep report sent.Remote: repeat alert or rvtlp to rvcol ea impedance warning on (b)(6) 2021.Previously noted on (b)(6) 2021 remote.Does not appear to be toning.Patient confirms that he has not heard any device toning.Trend appears stable, programmed bipolar.Battery and leads stable.(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: 17535952
• MDR Text Key: 321415586
• Report Number: MW5142844
• 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: 7121
• Patient Sequence Number: 1