BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 11175360 · Received January 14, 2021

    Report

    Report Number
    3004209178-2021-00821
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    December 9, 2020
    Report Date
    January 14, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000203849
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THEY HAD HEMATOMA AT THE POCKET SITE. HCP IS CONCERN ABOUT POTENTIAL INFECTION, THUS, HE IS LOOKING FOR DIRECTION AS TO HOW OTHER HCP'S MAY ADDRESS THE ISSUE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020 REPORTED THAT THE DOCTOR DID NOT CONFIRMED IF THEY HAD AN INFECTION BUT WAS PRESCRIBED ANTIBIOTICS SUCH AS CEPHALEXIN 500MG, METRONIDAZOLE 500MG AND DOXYCYCLINE HYC 100MG. ITWAS UNCLEAR TO THE PATIENT IF THE IMPLANT OR THERAPY CAUSED OR CONTRIBUTED TO THE HEMATOMA. THE PATIENT CLARIFIED THAT THE DOCTOR STATED THAT THE PROCEDURE RESULTED IN THE HEMATOMA, BUT THEY ARE NOT SURE IF IT WAS THE DEVICE OR THE PROCESS OF IMPLANTING THEM. THE PATIENT COMPLETED ALL THE ANTIBIOTICS PRESCRIBED. THE SWELLING AND THE PAIN WERE MOSTLY GONE. THE PATIENT BELIEVES THE BLEEDING AND SWELLING STOPPED BUT STILL HAS SOME BRUISING AND MILD DISCOMFORT ON (B)(6) 2021. THE PATIENT WERE SEEN AFTER SURGERY BY A DOCTOR ON (B)(6) 2020 AND (B)(6) 2020. THERE WERE NO DEVICE ISSUES REPORTED, AND NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71263 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97810 00763000203849

    Patients

    Seq Age Sex Outcome Treatment
    1