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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC. 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 09/26/2018
Event Type  malfunction  
Event Description
During an elective device upgrade, the tip of the right ventricular (rv) lead was accidentally cut off while opening the device pocket. While trying to replace the rv lead, the set screw of the rv lead was unable to be loosened from the device header. The device was explanted and replaced to resolve the event and the patient was in stable condition.
 
Manufacturer Narrative
The reported event of difficulty untightening the right ventricular (rv)-setscrew to remove the lead was confirmed. The analysis found the rv-setscrew was firmly stuck in the connector block and required destructive methods to separate it from the device connector. Analysis performed using scanning electron microscope 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 leads during the implant procedure the epoxy in the threads caused the setscrew to be locked in place which prevented removal of the lead. As a result of these findings, abbott is performing further investigation. No electrical anomalies were found. The battery voltage is above the elective replacement indicator (eri) near beginning of life (bol).
 
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Brand NameQUADRA ALLURE MP CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7940098
MDR Text Key123433260
Report Number2017865-2018-14907
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSP
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 12/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000058597
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2018
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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