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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP RF CRT-P; NO MATCH
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ABBOTT QUADRA ALLURE MP RF CRT-P; NO MATCH Back to Search Results
Model Number PM3262
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 04/09/2024
Event Type  malfunction  
Event Description
It was reported that decubitus resulting from infection.Device replacement was anticipated to resolve the event.The patient was stable and there were no adverse consequences.
 
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Brand Name
QUADRA ALLURE MP RF CRT-P
Type of Device
NO MATCH
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key19177066
MDR Text Key340999445
Report Number2017865-2024-39566
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734509091
UDI-Public(01)05414734509091(10)A000060191(17)191231
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P910023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/13/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2019
Device Model NumberPM3262
Device Lot NumberA000060191
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/09/2024
Initial Date FDA Received04/24/2024
Supplement Dates Manufacturer Received05/06/2024
05/13/2024
Supplement Dates FDA Received05/06/2024
05/13/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/02/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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