MAUDE Adverse Event Report: ABBOTT MEDICAL TENDRIL; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1688T, 1688T

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Date 02/20/2022

Event Type  malfunction  

Event Description

Atrial unipolar lead impedance warning on (b)(6) 2022 (pace/sense polarity programmed bipolar).Measured 190 ohms, threshold programmed 200 ohms.Device appears to be currently functioning as programmed.Based on the information at hand, the associated field personnel was not contacted regarding this event.Programming changes, at the time of the event were not requested.(b)(4).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): ABBOTT MEDICAL
• MDR Report Key: 17488935
• MDR Text Key: 320696612
• Report Number: MW5121634
• 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
• Report Date: 12/01/2022

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, 1688T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1