MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CONFIRM RX¿; DETECTOR AND ALARM, ARRHYTHMIA

Model Number DM3500

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 01/27/2019

Event Type  malfunction  

Event Description

The patient underwent an mri scan.The patient reported they had an implanted loop recorder device.The device was checked against the manufacturer's recommendations for safe mri procedure.The device was noted to be conditionally safe.The conditions included using 1.5 tesla field and implant not being placed within six weeks of the mri.The field was 1.5 t but the implant had been placed 37 days prior, short of the six week recommendation.The patient reported heating and a sharp pain in the area of the loop recorder.The mri was stopped.The patient is returning to cardiology clinic to assess the loop recorder at a later time.

• Brand Name: CONFIRM RX¿
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; saint paul MN 55117
• MDR Report Key: 8343598
• MDR Text Key: 136275491
• Report Number: 8343598
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2019
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10220 DA
• Patient Weight: 63