BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4092868 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17087
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 21, 2014
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# VA0199D, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD NOTICED A GRADUAL RETURN OF SYMPTOMS, INCLUDING NEEDING TO GO TO THE BATHROOM MORE OFTEN SUCH AS 10 MINUTES AFTER PREVIOUSLY GOING. THE PATIENT HAD HAD MORE INFECTIONS, WHICH WERE SYMPTOMS SHE USED TO HAVE. IT DAWNED ON HER THAT THERE MAY BE SOMETHING WRONG WITH THE IMPLANTABLE NEUROSTIMULATOR AND SHE WANTED TO SEE IF IT WAS ON, BUT SHE WASN¿T ABLE TO CHECK BECAUSE THE PATIENT PROGRAMMER WASN¿T WORKING FOR HER. WHEN SHE PUSHED THE BUTTON, NOTHING WOULD COME UP ON THE SCREEN. THE PATIENT PLANNED TO FIND NEW BATTERIES FOR THE PROGRAMMER. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571561 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention