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

Model Number 1488T

Device Problem High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Chronically high thresholds (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TENDRIL SDX LEADS
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17524562
• MDR Text Key: 321265702
• Report Number: MW5131508
• 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: 09/01/2022

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: 1488T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1