MAUDE Adverse Event Report: UNKNOWN RA LEAD, RV LEAD; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 14881, 1488T

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Appropriate Term/Code Not Available (3191); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Right atrial (ra) lead and right ventricular (rv) lead exhibited high thresholds.The ra lead and rv lead were capped and replaced.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RA LEAD, RV LEAD
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17525663
• MDR Text Key: 321371719
• Report Number: MW5132604
• Device Sequence Number: 1
• Product Code: NVN
• 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: 01/05/2022

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: 14881, 1488T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Treatment: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR R