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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 Over-Sensing (1438)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2020
Event Type  malfunction  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
During an in clinic follow-up, oversensing due to a diagnostic test that resulted in episodes of inappropriate mode switching was noted on the device. Technical support recommended reprogramming to resolve the event, however, no intervention has been performed at this time. The patient was in stable condition and will continue to be monitored.
 
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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 Key10839672
MDR Text Key216313102
Report Number2017865-2020-17759
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000048525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2017
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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