BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7141208 · Received December 21, 2017

    Report

    Report Number
    3004209178-2017-26527
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    December 19, 2017
    Report Date
    March 24, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT#: 0213587579, IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE RESULTS OF THE SWAB AS FOLLOWS: GRAM STAIN: NO ORGANISMS SEEN; CULTURE: STAPHYLOCOCCUS LUGDUNENSIS SCANT; ANTIBIOTIC GIVEN PENICILLIN G, DI(FLU)CLOXACILLIN, CLINDAMYCIN, CEFAZOLIN.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED A SYSTEM EXPLANT DUE TO INFECTION. NO FACTORS NOTED TO HAVE LED/CONTRIBUTED TO THE EVENT, NO TROUBLESHOOTING NOTED PERFORMED, ACTIONS TAKEN NOTED AS EXPLANT. THE ISSUE WAS NOTED AS NOT RESOLVED, AS WELL AS RESOLVED AT THE TIME OF THE REPORT. IT WAS NOTED THAT A SWAB WAS TAKEN AT THE TIME OF EXPLANT, BUT THE RESULTS WERE NOT YET KNOWN. IT WAS NOTED THAT THE CONSUMER DEVELOPED AN INFECTION AT THE IMPLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919723 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention