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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3262
Device Problem Misconnection (1399)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2018
Event Type  malfunction  
Event Description
Related manufacturer reference numbers: 2017865-2018-12748, 2938836-2018-10101. During an implant procedure, there was decreased r-wave sensing amplitude noted on the device; therefore, the physician attempted to disconnect the leads to remeasure the sensing value, but there was difficulty loosening the right atrial (ra) and right ventricular (rv) leads from the header of the device. The device and both ra and rv leads were explanted and replaced to resolve this event. The patient was stable.
 
Manufacturer Narrative
The reported event of the doctor being unable to untighten the right atrial (ra)-setscrew was confirmed. Electrical anomaly was not confirmed. The analysis found on ra-setscrew was firmly stuck in its connector blocks and required destructive methods to separate them from the device connectors. Analysis performed using scanning electron microscope confirmed the foreign material found in the connector block threads to be epoxy, which caused the setscrews to become lodged. When the setscrew was tightened on the leads during the implant procedure the epoxy in the threads caused the setscrews to be locked in place which prevented removal of the leads. As a result of these findings, abbott is performing further investigation.
 
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Brand NameQUADRA ALLURE MP RF 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 Key7829665
MDR Text Key118892205
Report Number2017865-2018-12747
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P910023
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 11/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberPM3262
Device Lot NumberP000060473
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2018
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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