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

Model Number 1688TC

Device Problems Ambient Noise Problem (2877); Impedance Problem (2950)

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

Event Type  malfunction  

Event Description

It was reported that this right atrial (ra) lead triggered a lead safety switch (lss) due to a high out-of-range pace impedance measurement greater than 3000 ohms.Following the lss to unipolar, there were numerous inappropriately stored atrial tachy response (atr) episodes.Unipolar pacing threshold was 0.5v, pace impedance was 341 ohms, and p-wave amplitude in bipolar was 7mv.The noise was reproducible with arm movements, but was not oversensed.It was noted that ra pace impedance measurements were stable over the past year, and the impedance measurements had spiked abruptly.It was noted that the patient had been gardening and doing some heavy lifting recently.Programming changes were made and it was noted that the patient was not pacer dependent.This ra lead remains in service.No 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: 17529642
• MDR Text Key: 321331721
• Report Number: MW5136567
• 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: 07/19/2022

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: 1688TC
• Device Lot Number: CYN019027
• Patient Sequence Number: 1