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

Model Number 2088TC

Device Problems Patient-Device Incompatibility (2682); Device Sensing Problem (2917)

Patient Problem Cardiovascular Insufficiency (4445)

Event Date 06/06/2012

Event Type  malfunction  

Event Description

Boston scientific received information stating: during pacemaker implant a st.Jude 2088tc was used.After several repositioning this lead also had poor r wave sensing with some positions having poor thresholds.Dr.Concluded due to severe scarring of the heart muscles it was difficult to find a lead position with good sensing and thresholds.The difficulty was not due to the lead but the patient's heart.Lead 2088tc was positioned were there were good thresholds but poor sensing and sensitivity on device was programmer to 0.5 mv.Dr g nair event date (b)(6) 2012 canada 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
• MDR Report Key: 17520249
• MDR Text Key: 321045345
• Report Number: MW5127197
• 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: 07/13/2012

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: 2088TC
• Patient Sequence Number: 1