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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 Failure to Interrogate (1332)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
No conclusion available. The reported field event of inability to interrogate was confirmed. The device had no output and was not able to be interrogated when received. The device was cut open and it regained telemetry and output, which is consistent with hybrid anomaly. Visual and x-ray inspection did not find any anomaly that could cause the reported event. Further analysis performed after reloading product code did not find any anomaly; loss of telemetry and output was not able to be reproduced. Device history record was also reviewed and all manufacturing operations have been completed.
 
Event Description
Prior to implant, the device was not able to be interrogated, so a different device was used. There were no adverse consequences and the patient was stable following the procedure.
 
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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 Key7131206
MDR Text Key115224169
Report Number2017865-2017-36375
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 02/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000046198
Other Device ID Number05414734510097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2017
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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