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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD); DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC, INC. IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD); DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTBA2QQ
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
It was reported that this implantable cardioverter defibrillator (icd) was explanted for an unspecified reason.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key18859026
MDR Text Key337353952
Report NumberMW5152477
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 02/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberDTBA2QQ
Was Device Available for Evaluation? No
Patient Sequence Number1
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