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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; Pulse generator, permanent, implantable

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; Pulse generator, permanent, implantable Back to Search Results
Model Number CD2357-40Q
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/25/2023
Event Type  Injury  
Event Description
Related manufacturer reference number: 2017865-2023-44072 / 2017865-2023-44074 it was reported that the patient presented for a scheduled generator upgrade procedure.During the procedure, the implantable cardioverter defibrillators set screw appeared stripped and could not be loosened.While attempting to remove the atrial lead from the device's header, the lead pin was damaged and appeared sprung.Ultimately, the lead was capped and replaced on (b)(6) 2023.The device was replaced.After the procedure on the same day, the patient developed bleeding at the pocket site and underwent another successful procedure for reconciliation of the bleeding.The patient tolerated the procedure well and was in stable condition.
 
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Brand Name
FORTIFY ASSURA DR ICD, US
Type of Device
Pulse generator, permanent, implantable
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 Key17795169
MDR Text Key324001743
Report Number2017865-2023-46693
Device Sequence Number1
Product Code NVZ
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 09/21/2023
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? No
Device Operator Health Professional
Device Model NumberCD2357-40Q
Device Lot NumberP000167410
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/25/2023
Initial Date FDA Received09/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2023
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
DURATA TACHY; TENDRIL
Patient Outcome(s) Required Intervention; Other;
Patient Age86 YR
Patient SexMale
Patient Weight73 KG
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