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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC CLARIA MRI CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC, INC. MEDTRONIC CLARIA MRI CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTMA1D1 CLARIA MRI CRT-D
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Cardiac Arrest (1762); Brain Injury (2219); Coma (2417)
Event Date 08/28/2021
Event Type  Death  
Event Description
Patient's cardio defibrillator malfunctioned while at home.The lead failed 6 times to supply sufficient voltage for defibrillation.Patient experienced cardiac arrest, anoxic brain injury, coma and was made comfort measures only.Patient passed away shortly after.Interrogation shows normal lead function in terms of impedance, sensing and capture thresholds.However, device failed to deliver adequate energy needed for successful defibrillation.In discussion with device manufacturer representatives, this appears to be consistent with a rv lead malfunction.Cxr does not reveal any evidence of lead malposition or fracture.Fda safety report id # (b)(4).
 
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Brand Name
MEDTRONIC CLARIA MRI CRT-D
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key12421262
MDR Text Key270063465
Report NumberMW5103693
Device Sequence Number1
Product Code NIK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/31/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDTMA1D1 CLARIA MRI CRT-D
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age64 YR
Patient Weight60
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