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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ABBOTT QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3562
Device Problem No Pacing (3268)
Patient Problem Arrhythmia (1721)
Event Date 06/21/2021
Event Type  Injury  
Event Description
It was reported that the patient was hospitalized due to an arrhythmia. Loss of pacing was observed on the device. Diagnostic imaging was performed and subclavian crush was observed on the right ventricular (rv) lead. The device and rv lead were explanted and replaced to resolve the event. The patient was stable and there were no adverse consequences. Related manufacturer reference number: 2017865-2021-25840.
 
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Brand NameQUADRA ALLURE MP CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key12173663
MDR Text Key261707763
Report Number2017865-2021-25838
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734510097
UDI-Public05414734510097
Combination Product (y/n)N
Reporter Country CodeLH
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000080576
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/15/2021 Patient Sequence Number: 1
Treatment
TENDRIL RV LEAD
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