MAUDE Adverse Event Report: ST. JUDE MEDICAL RA LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1688TC

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877); Impedance Problem (2950); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the implantable cardioverter defibrillator (icd) exhibited a code 1005 indicative of an open circuit condition detected during shock delivery.Out of range shock impedance measurements were noted.Low out of range impedance measurements were observed on this right atrial (ra) lead as well as noise that was oversensed and loss of capture (loc).It is planned to perform a lead revision and replace both leads as well as a device upgrade in the near future.Additional information was received that a revision procedure was performed and the brady and tachy therapy of the device were deactivated.The rv lead and this ra lead were capped and replaced.No additional adverse patient effects were reported.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: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17489544
• MDR Text Key: 320708682
• Report Number: MW5122079
• Device Sequence Number: 1
• Product Code: DTB
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1688TC
• Patient Sequence Number: 1