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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA VR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA VR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD1357-40C
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2023
Event Type  malfunction  
Event Description
It was reported that a patient presented to the emergency room with back-up vvi mode noted on the patient's implantable cardioverter defibrillator.Corrective programming changes were made to restore the device.The patient was stable throughout.
 
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Brand Name
FORTIFY ASSURA VR ICD, US
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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 Key16812898
MDR Text Key313993262
Report Number2017865-2023-18421
Device Sequence Number1
Product Code LWS
UDI-Device Identifier05414734507943
UDI-Public05414734507943
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P910023
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 04/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Model NumberCD1357-40C
Device Catalogue NumberCD1357-40C
Device Lot NumberA000036490
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/06/2023
Initial Date FDA Received04/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
RIGHT VENTRICULAR LEAD
Patient Age72 YR
Patient SexMale
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