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

Model Number 1688TC

Device Problems Signal Artifact/Noise (1036); Deformation Due to Compressive Stress (2889); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 2006 and remains implanted at this time.A call placed to technical services on (b)(6) 2013 states representative called about to do generator change with dr.(b)(6).Impedance on this lead went from 420 at implant to 380 today.Representative did think there was evidence of some inappropriate sensing in past.On a follow up call placed on the same day of the first call states lead was kinked.There had been noise noted on atrial channel prior to change out.Physician also noted some abrasion of insulation, but no blood in lumen.Physician elected to use lead repair kit to repair lead.Representative stated that impedance was in the 400 range and then over the past year had decreased to the 370-380 ohm range.After repairing lead impedance went back up to 450 ohms.Threshold was always good.Dr.(b)(6) did procedure at (b)(6).No additional 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: 17516906
• MDR Text Key: 321225906
• Report Number: MW5123855
• 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: 06/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1688TC
• Patient Sequence Number: 1