MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. RAITA; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 1581-65

Device Problem Low Sensing Threshold (2575)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Caller asking how to resolve a patients chronically low rvtip/rvcoil impedance alerts that are slightly below the 200 ohm impedance alert threshold? explained that they may want to consider turning off the rvpacing impedance out of range alert and relying on the patient's rv lia alert lo notify them of any potential future issues with the rvpace/sense.605170684.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RAITA
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.
• MDR Report Key: 17530518
• MDR Text Key: 321347091
• Report Number: MW5137437
• Device Sequence Number: 1
• Product Code: LWS
• 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: 09/01/2022

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: 1581-65
• Patient Sequence Number: 1