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

Model Number 1488TC-46

Device Problems Display or Visual Feedback Problem (1184); Under-Sensing (1661); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2022

Event Type  malfunction  

Event Description

Suspected atrial under-sensing during recorded episodes, programmed atrial sensitivity 1.2 mv atrial unipolar lead impedance warning on (b)(6) 2022.Atrial polarity switch on (b)(6) 2022.Last programmer session on (b)(6) 2022 (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TENDRILL SDX
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17488873
• MDR Text Key: 320709671
• Report Number: MW5121572
• 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: 1488TC-46
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1