MAUDE Adverse Event Report: ST. JUDE MEDICAL TENDRIL SDX; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number 1488TC-46

Device Problems High Sensing Threshold (2574); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Clinician called looking for eri battery voltages device is currently 2.63v at 5331 ohms clinician mentioned rv lead has noise and high thresholds.Rv lead is a st jude lead.No symptoms, but they will be replacing the rv l ead at generator change." lead manufactured by st jude.Case: (b)(4) /(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TENDRIL SDX
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17535097
• MDR Text Key: 321283561
• Report Number: MW5141997
• Device Sequence Number: 1
• Product Code: DXY
• 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: 05/03/2021

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: 1488TC-46
• Patient Sequence Number: 1