MAUDE Adverse Event Report: ST. JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1688T

Device Problems Failure to Capture (1081); Low impedance (2285)

Patient Problem Syncope/Fainting (4411)

Event Type  Injury  

Event Description

This rv lead was implanted on (b)(6) 2016 and remains implanted at this time.A call was placed to technical services on (b)(6) 2016 stating that there was a loss of capture, syncope and a slight drop of impedance to 330 ohms and low er for the auto threshold.The physician was dr.(b)(6) at (b)(6).No other information is available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17530800
• MDR Text Key: 321109581
• Report Number: MW5137717
• 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: 01/12/2017

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: 08/12/2023
• Patient Sequence Number: 1