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

Model Number 1688T AND 7001

Device Problem Under-Sensing (1661)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Low p wave.Device appears to be undersensing on atrial lead.Hv imp 66 ohms.(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: 17525044
• MDR Text Key: 321313700
• Report Number: MW5131986
• 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: 02/02/2021

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 AND 7001
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1