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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2357-40C
Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2022
Event Type  Injury  
Event Description
It was reported that the patient was in the hospital.An interrogation of the implantable cardioverter defibrillator revealed that inappropriate shocks were delivered for an episode of atrial fibrillation with high ventricular rate response in the ventricular tachycardia zone.Drugs were administered and programming interventions were made.The patient was in stable condition.
 
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Brand Name
FORTIFY ASSURA DR 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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key15446692
MDR Text Key300150239
Report Number2017865-2022-38556
Device Sequence Number1
Product Code NVZ
UDI-Device Identifier05414734508063
UDI-Public05414734508063
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 09/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Model NumberCD2357-40C
Device Catalogue NumberCD2357-40C
Device Lot NumberA000118794
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/28/2022
Initial Date FDA Received09/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2021
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 ATRIAL LEAD; RIGHT VENTRICULAR LEAD
Patient Outcome(s) Other;
Patient Age81 YR
Patient SexMale
Patient Weight80 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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