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

Model Number 1646T

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Intermittently (1443)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/23/2004

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2004 and was capped on (b)(6) 2014 due to noise, oversensing and pacing not delivered when required.The physician was dr.(b)(6).No other information is available.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: 17518217
• MDR Text Key: 321291030
• Report Number: MW5125165
• 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: 03/31/2014

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: 1646T
• Patient Sequence Number: 1