MAUDE Adverse Event Report: ABBOTT MEDICAL ABBOTT CDDRA500Q GALLANT DR ICD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number ABBOTT CDDRA500Q GALLANT DR ICD

Device Problems Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/02/2022

Event Type  Injury  

Event Description

Patient with icd and pacer device underwent mri, the device was a newer one known as abbott gallant icd and crt-d this abbott gallant icd and crt-d.This abbott gallant icd and crt-d device has a 3-step process to provide for mri safety.Cardiology nurse articulated all steps in process and competency was verified.There was a miss step in last step of the mri safety process (save, printout, confirm).The miss step was not detected at time by any warnings.Subsequently at initiation of mri the icd shut off.Manufacturer was notified, representative arrived at hospital the device was interrogated by manufacturer.Manufacturer could not confirm hardware damage.Manufacturer recommends replacement of icd.Patient scheduled for new device.The manufacturer could confirm pacing feature.Device currently in doo mode, no icd capacity.Pt will await for replacement of device at a later time.Fda safety report id# (b)(4).

• Brand Name: ABBOTT CDDRA500Q GALLANT DR ICD
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 14398010
• MDR Text Key: 291730424
• Report Number: MW5109684
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ABBOTT CDDRA500Q GALLANT DR ICD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White