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

Model Number 1888TC

Device Problems Electromagnetic Interference (1194); Decreased Sensitivity (2534)

Patient Problem Tachycardia (2095)

Event Type  Injury  

Event Description

This rv lead was implanted on (b)(6) 2009 and remains implanted as of the present.A call placed to technical services on 04/12/2018 stating that ventricular episode was observed at 4:00am on april 2 that looks like myopotential and is reproducible when patient rolls from side to side but was not oversensed.Few drop in impedance from around 450-500 down to 350 ohm was also observed.The patient had an underlying rhythm of approximately 30 and a 2 second pause.The health care professional (hcp) stated it looked like electromagnetic interference with some fuzz and decrease the sensitivity.The following physician was dr.(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: 17535897
• MDR Text Key: 321136129
• Report Number: MW5142790
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1888TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1