BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4409578 · Received January 12, 2015

    Report

    Report Number
    3004209178-2015-00548
    Event Type
    Malfunction
    Date Received
    January 12, 2015
    Report Date
    December 17, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V896640, IMPLANTED: (B)(6) 2012, 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 PATIENT FELL DOWN SEVERAL TIMES AND THE HEALTHCARE PROVIDER (HCP) HAD TO ¿READJUST SOME WIRES OR LEADS OR SOMETHING.¿ THE REPORTER WAS NOT SURE WHAT DATE THE PATIENT FIRST FELL OR WHEN SHE WAS REPROGRAMMED BY THE HCP. THE REPORTER DID NOT BELIEVE THE THERAPY WAS HELPING WITH THE PATIENT¿S SYMPTOMS. AT THE LAST HCP VISIT, ABOUT A MONTH AGO, THE HCP PRESCRIBED A MEDICATION AND TOLD THE PATIENT A MANUFACTURER REPRESENTATIVE MIGHT BE ABLE TO COME REPROGRAM HER AT THE NEXT VISIT. WITH ASSISTANCE THE REPORTER WAS ABLE TO SEE THAT THE IMPLANT WAS ON AND ON PROGRAM 4 AT 0.9 VOLTS. THE REPORTER WAS ABLE TO TURN IT OFF AND BACK ON NORMALLY. NO CLEAR INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26347 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1