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

Model Number 377177

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Ra lead cisiooged on (b)(6) 2021 during a rv lead revision procedure.Ra lead was explanted 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
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531122
• MDR Text Key: 321429514
• Report Number: MW5138037
• 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: 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: 377177
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1