MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number MODEL 1388T CRDM NON-DEFIB LEAD

Device Problems Device Displays Incorrect Message (2591); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Lead warning noted on rv lead impedance trending 17 mar 2018 rv lead is programmed off." lead manufactured by st.Jude.Case: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.
• MDR Report Key: 17528647
• MDR Text Key: 321276795
• Report Number: MW5135577
• 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: 11/02/2020

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: MODEL 1388T CRDM NON-DEFIB LEAD
• Patient Sequence Number: 1