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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 Misconnection (1399)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2020
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
During the implant procedure, the set screw could not be secured in the device header. A new device was used to complete the procedure, and the patient was stable with no consequences.
 
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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 Key10750454
MDR Text Key213630561
Report Number2017865-2020-16320
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeFR
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 01/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000102658
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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