MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; NO MATCH

Model Number CDDRA500Q

Device Problems Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959); Compatibility Problem (2960)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for a follow-up in clinic for a magnetic resonance imaging (mri) procedure.It was noted that the implantable cardioverter defibrillator (icd) inappropriately switched to backup mode due to not following the correct mri procedure protocol.This led to loss of backup defibrillation therapy.The patient was asymtpomatic.The icd was reprogrammed successfully, and the patient left stable in condition.

Manufacturer Narrative

Corrected data: correction report needed to adjust the h6 codes to reflect the proper mri protocol was not followed.

• Brand Name: GALLANT DR
• Type of Device: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17719478
• MDR Text Key: 323067595
• Report Number: 2017865-2023-42685
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA500Q
• Device Lot Number: P000155761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1