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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTPB2QQ
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported that the device was explanted due to unknown product performance issue.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
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MEDTRONIC
MDR Report Key17537435
MDR Text Key321438649
Report NumberMW5144313
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberDTPB2QQ
Patient Sequence Number1
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