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

Model Number 1688T

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

Patient Problem Insufficient Information (4580)

Event Date 10/29/2022

Event Type  malfunction  

Event Description

Intermittent low impedance alerts for rvtip-rvcoil (b)(6) 2022 09:00:13 'rvtip to rvcoil lead impedance 190 ohms.200 ohms (b)(6) 2022 03:00:13 'rvtip to rvcoil lead impedance 190 ohms.200 ohms impedance has been trending right near 200ohms for the viewable past with a random dip to 190ohms.(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: 17488849
• MDR Text Key: 320723210
• Report Number: MW5121548
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1