MAUDE Adverse Event Report: ST. JUDE MEDICAL TENDRIL; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1688T

Device Problems Signal Artifact/Noise (1036); Therapeutic or Diagnostic Output Failure (3023); High Capture Threshold (3266)

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

Event Type  malfunction  

Event Description

It was reported that the system with the cardiac resynchronization therapy defibrillator (crtd) and this right atrial (ra) lead showed atrial automatic threshold detected as higher than programmed amplitude or suspended.Patient having ra lead noise that appears to be non physiological on an atrial tachv response (atr) episode as it isolated and just on this ra lead channel.There was also a failure core for low evoke response.Various reprogramming options were recommended.The crt-d and this ra lead remain 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: TENDRIL
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17490088
• MDR Text Key: 320710501
• Report Number: MW5122606
• Device Sequence Number: 1
• Product Code: NVZ
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1688T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1