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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE QUADRA RF CRT-P; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE QUADRA RF CRT-P; No Match Back to Search Results
Model Number PM3242
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/26/2023
Event Type  malfunction  
Event Description
It was reported that patient presented in clinic for routine follow-up.Upon interrogation, it was found that patient's pacemaker exhibited diagnostic anomaly in which device longevity was calculated incorrectly.No intervention was performed.The patient was stable.
 
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Brand Name
ALLURE QUADRA RF CRT-P
Type of Device
No Match
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key17330212
MDR Text Key319375624
Report Number2017865-2023-35899
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734507912
UDI-Public05414734507912
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2016
Device Model NumberPM3242
Device Catalogue NumberPM3242
Device Lot NumberA000001428
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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