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

Model Number MODEL 7122

Device Problems Over-Sensing (1438); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Rv lea integrity alert triggered for 2 high rate-ns an 133810 short v-v intervals.Oversensing noted on some stored egma?'tms.(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: 17525113
• MDR Text Key: 321460448
• Report Number: MW5132055
• 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: 12/01/2021

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: MODEL 7122
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1