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U.S. Department of Health and Human Services

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

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ABBOTT QUADRA ALLURE CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3542
Device Problems High impedance (1291); Misconnection (1399)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2019
Event Type  Injury  
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
It was reported that high pacing lead impedance (pli) was observed on the left ventricular lead. The set screw in the device header was not fully tightened, which was the cause of the high pli. Additional surgery was performed and the set screw was tightened to resolve the event. The patient was stable following the procedure and there were no adverse consequences.
 
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Brand NameQUADRA ALLURE 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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8800670
MDR Text Key151403877
Report Number2017865-2019-11094
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734510080
UDI-Public05414734510080
Combination Product (y/n)N
Reporter Country CodePL
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 07/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2020
Device Model NumberPM3542
Device Catalogue NumberPM3542
Device Lot NumberP000080871
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 Received07/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2019
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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