BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3514329 · Received December 11, 2013

    Report

    Report Number
    3004209178-2013-23381
    Event Type
    Injury
    Date Received
    December 11, 2013
    Report Date
    November 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V933650, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIGHT AFTER THE PATIENT WAS IMPLANTED SHE WENT TO THE BATHROOM AND HEARD A POP. THE FOLLOWING MORNING THE PATIENT¿S CAREGIVER TOLD HER THERE WAS A ¿WIRE STICKING OUT OF HER BODY.¿ THE PATIENT SAW HER HEALTHCARE PROVIDER (HCP) AND HE TOLD HER ¿IT WAS PRETTY MUCH HEALED ALREADY.¿ THE PATIENT TOLD HER HCP THAT ¿HE HAD TO FIX IT¿ AND THIS WAS WHEN HE TOLD HER THAT ¿HE HAD GOOD NEWS AND BAD NEWS. HE FIXED THE WIRES, BUT NOW IT MIGHT NOT WORK.¿ THE PATIENT STATED THAT SHE HAD BEEN ¿GOING THROUGH THIS FOR THE LAST YEAR AND HAD FOUR UNNECESSARY SURGERIES.¿ THE PATIENT STATED THAT SHE HAD TO HAVE A THIRD SURGERY TO ¿FIX THE WIRE AND THE STIMULATOR BECAUSE THE STIMULATOR WAS SPINNING AROUND IN HER BODY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647683 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention