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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 Problem Misconnection (1399)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2019
Event Type  malfunction  
Event Description
Related manufacturer report number: 2017865-2019-05576. It was reported that there was a loss of sensing and an increase in pacing threshold on the right atrial (ra) lead. During the ra lead repositioning procedure, the ra lead could not be unscrewed from the header of the device. The ra lead was cut and the device was explanted and replaced. The distal portion of the ra lead was capped and remained implanted. The patient was stable with no adverse consequences reported.
 
Manufacturer Narrative
The reported device was returned for evaluation. The analysis revealed that the atrial setscrew was firmly stuck in the connector block and required destructive methods to separate it from the device connector. Analysis was performed using a scanning electron microscope and confirmed the foreign material found in the connector block threads to be epoxy, which caused the setscrew to get stuck. When the setscrew was tightened on the lead during the implant procedure the epoxy in the threads caused in the setscrew to be locked in place which prevented removal of the lead. A manufacturing anomaly may have occurred that left or caused the epoxy to be in the connector block threads. As a result of these findings, abbott is performing further investigation. Electrical testing was performed and revealed no anomalies. The battery voltage is above elective replacement indicator (eri) near beginning of life (bol).
 
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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 Key8520760
MDR Text Key142337517
Report Number2017865-2019-05575
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeIT
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 08/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model NumberPM3542
Device Catalogue NumberPM3542
Device Lot NumberA000070336
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2018
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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