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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 Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2017
Event Type  malfunction  
Manufacturer Narrative
The reported event of the lv lead being unable to be fully inserted into the lv port was not confirmed during testing of the device in the laboratory. The connector was tested with is4 leads which fully inserted into the lv connector without an anomaly. No anomalies or obstructions were found in the lv connector bore. The reported event is consistent with the lv-setscrew being turned too far down in the bore such that it was blocking full lead insertion in the connector.
 
Event Description
During implant, it was difficult to screw the connector of the left ventricular lead into the device header. The set screw could not be tightened, so a different device was implanted. The patient's condition was stable and there were no adverse consequences. Following the procedure, the set screw was tested and was able to be tightened into the device header.
 
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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 Key6999435
MDR Text Key109300444
Report Number2017865-2017-34067
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeFR
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 01/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Model NumberPM3262
Device Lot NumberP000046260
Other Device ID Number05414734509091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2017
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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