BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAKOTA

    MDR report key: 16268436 · Received January 30, 2023

    Report

    Report Number
    3005099803-2023-00317
    Event Type
    Injury
    Date Received
    January 30, 2023
    Date of Event
    December 1, 2018
    Report Date
    January 30, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE REPORTED DATE OF (B)(6) 2018. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. PATIENT CODE E061202 CAPTURES THE REPORTABLE EVENT OF MYOCARDIAL INFARCTION. IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT CARDIAC CATHETER AND CORONARY STENT. IMPACT CODE F08 IS BEING USED FOR THE REPORTABLE EVENT OF PATIENT COMPLICATION OF READMISSION FOR CARDIAC CATHETER AND CORONARY STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THROUGH A POST MARKET CLINICAL FOLLOW UP (PMCF) OF RETROSPECTIVE DATA COLLECTION, THAT A DAKOTA WAS USED DURING A REMOVAL, CALCULUS, URETER, URETEROSCOPIC PROCEDURE PERFORMED ON (B)(6) 2018. DURING PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. THE PATIENT WAS READMITTED CARDIAC CATHETER AND CORONARY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775161 DAKOTA DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| H