MAUDE Adverse Event Report: ST. JUDE MEDICAL TENDRIL SDX; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number 1688TC

Device Problems Display or Visual Feedback Problem (1184); Fracture (1260); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2021

Event Type  malfunction  

Event Description

Rv lead from st jude is fractured and caller tells me that is a known issue they dealt with last year.She believes it has already been reported.Rv is programmed sub threshold.Rv bipolar lead impedance warning on (b)(6) 2020.Rv unipolar lead impedance warning on (b)(6) 2021.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TENDRIL SDX
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17525191
• MDR Text Key: 321451351
• Report Number: MW5132133
• Device Sequence Number: 1
• Product Code: DXY
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1688TC
• Patient Sequence Number: 1