BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3091576 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07235
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V251861, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS ¿NOT AN INFECTION.¿ FIVE DAYS LATER IT WAS REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY BUT HAD SOUGHT FURTHER HELP. THE PATIENT HAD APPOINTMENTS ON (B)(6) 2013. THE PATIENT WROTE THAT SHE WAS SCHEDULED TO HAVE ¿STAGE 1 AND STAGE 2 OR STIMULATION TEST¿ ON (B)(6) 2013. THE FOLLOW UP WAS SCHEDULED FOR (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD TWO INFECTIONS IN (B)(6), RESPECTIVELY. IT WAS STATED THAT "IN (B)(6) IT STOPPED WORKING". IT WAS INDICATED THE PATIENT "COULD NOT TURN IT ON OR OFF". IT WAS NEVER CONFIRMED WHETHER THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS WORKING OR NOT. ABOUT A WEEK PREVIOUS TO REPORT, THE PATIENT WAS "CHECKED OUT" FOR INFECTIONS. IT WAS UNCLEAR IF THE PATIENT STILL HAD AN INFECTION AT THE TIME OF THE REPORT. IT WAS NOTED THAT WHEN THE INS WAS ON, THE PATIENT 'NEVER GOT THESE INFECTIONS" AND THEY NOTICED A 'BIG DIFFERENCE" WHEN THE DEVICE WAS ON. IT WAS FURTHER STATED THAT "THIS DEVICE WORKED EVEN BETTER THAN THE ONE IMPLANTED BEFORE IT". ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194248 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention