BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAKOTA

    MDR report key: 16264425 · Received January 30, 2023

    Report

    Report Number
    3005099803-2023-00296
    Event Type
    Injury
    Date Received
    January 30, 2023
    Date of Event
    January 1, 2017
    Report Date
    March 16, 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 A BEST ESTIMATE BASED ON THE REPORTED DATE OF (B)(6) 2017. THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. PATIENT CODE E010701 CAPTURES THE REPORTABLE EVENT OF ALTERED MENTAL STATUS. IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION.

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE REPORTED DATE OF (B)(6) 2017. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: PATIENT CODE E010701 CAPTURES THE REPORTABLE EVENT OF ALTERED MENTAL STATUS. IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA BASKET WAS USED IN THE URETER DURING A BILATERAL FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED IN (B)(6) 2017. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ALTERED MENTAL STATUS. PATIENT WAS THEN READMITTED FOR ANTIBIOTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA BASKET WAS USED IN THE URETER DURING A REMOVAL, CALCULUS, URETER, URETEROSCOPIC PROCEDURE PERFORMED IN (B)(6) 2017. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ALTERED MENTAL STATUS. PATIENT WAS THEN READMITTED FOR ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6076 DAKOTA DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention| H