MAUDE Adverse Event Report: ST. JUDE MEDICAL TENDRIL STS; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 2088TC

Device Problem Protective Measures Problem (3015)

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

Event Type  malfunction  

Event Description

It was reported that an alert was detected for right atrial automatic threshold (raat) suspension.Technical services reviewed device data and determined the raat failed to measure the threshold due to low evoked response (er) since implant.This involved lead is a non-boston scientific product.Reprogramming options were discussed.The pacemaker system remains in service and there were no adverse patient effects reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TENDRIL STS
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17489944
• MDR Text Key: 320708439
• Report Number: MW5122463
• Device Sequence Number: 1
• Product Code: LWS
• 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: 2088TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1