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

Model Number CDHFA500Q

Device Problems Failure to Interrogate (1332); Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)

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

Event Date 03/28/2024

Event Type  Injury  

Event Description

It was reported that the patient assisted their wife during an mri (magnetic resonance imaging).After the mri, the patient received an alert that their implantable cardioverter defibrillator (icd) disconnected from the mobile application.The patient was brought into clinic and it was noted the icd was in backup mode.The device was explanted and replaced.The patient condition was stable.

Event Description

New information received indicates that therapies were deactivated due to the back-up mode.An attempt to reset and restore the device was attempted but it was unsuccessful.The patient was stable.

Manufacturer Narrative

The reported event of backup operation was confirmed.Final analysis of device image found the device went into backup mode due to a power-on-reset as a result of off-label mri exposure.After the device was restored from backup mode, functional testing was performed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: GALLANT HF
• 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: 19127239
• MDR Text Key: 340408698
• Report Number: 2017865-2024-38947
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: (01)05415067032010(10)S000087896(17)240831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Lot Number: S000087896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/23/2024; 05/03/2024
• Supplement Dates FDA Received: 04/24/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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
• Treatment: 1458Q/86 QUARTET LEADS; 2088TC/52 TENDRIL LEADS; 7122Q/65 DURATA TACHY MRI LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male