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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 11/06/2019
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 implant procedure, the left ventricular lead was unable to be connected to the device header. The device was explanted and replaced to resolve the event. The patient was stable.
 
Manufacturer Narrative
Analysis testing found the lv-setscrew was blocking lead insertion into the lv-connector. Analysis found the lv-setscrew was 100% stripped. The stripped setscrew indicates it was being manipulated by the user of the wrench in the field. For analysis testing the setscrew was backed out from blocking the connector port. Is-4 test leads could then be fully inserted into the lv-connector with normal insertion force. All connector dimensions were within specification. No device anomalies were found. The problem is related to the user¿s use of the wrench that at some point turned the setscrew down blocking lead insertion while stripping the setscrew.
 
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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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key9328661
MDR Text Key166596710
Report Number2017865-2019-16312
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGM
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 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000084094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2019
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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