MAUDE Adverse Event Report: ABBOTT MEDICAL TENDRIL SDX; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number 1488TC

Device Problems Display or Visual Feedback Problem (1184); High Sensing Threshold (2574); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

Atrial unipolar lead impedance warning on (b)(6) 2020 due to ra unipolar 190 ohms.Thresholds less than 200 or greater than 3000.Last measured 380 ohms.(b)(4).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): ABBOTT MEDICAL
• MDR Report Key: 17528694
• MDR Text Key: 321162187
• Report Number: MW5135624
• 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: 02/02/2021

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
• Patient Sequence Number: 1