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

Model Number 1882TC

Device Problems Pacing Problem (1439); Loss of Threshold (1633)

Patient Problem Tachycardia (2095)

Event Date 03/14/2018

Event Type  Injury  

Event Description

This ra lead was implanted on (b)(6) 2018 and was revised on (b)(6) 2018.A call was placed to technical services on 04/27/2018 stating that fast intrinsic rate was tracked.No pacing inhibition and noted that pacemaker mediated tachycardia had odd timing of atrial electrogram (egm).In addition, the atrial threshold had dropped.The physician was dr.(b)(6) at (b)(6) medical center in (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: 17524711
• MDR Text Key: 321137725
• Report Number: MW5131655
• 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: 07/10/2018

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: 1882TC
• Patient Sequence Number: 1