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

Model Number 1699TC

Device Problems Pacing Inadequately (1442); Incorrect Interpretation of Signal (1543)

Patient Problem Dyspnea (1816)

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 2009 and remains implanted at this time.A call was placed to technical services on 5/3/2017 stating that patient had shortness of breathing with minute ventilation on.They were asked to turn off minute ventilation.Still short of breath and histogram were flat.There were lot of spikes noted on sensor trending.Atrial was programmed to unipolar due to noise.No physician or hospital known.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: 17534622
• MDR Text Key: 321409435
• Report Number: MW5141523
• 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: 06/20/2017

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: 1699TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1