BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2951357 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01508
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    January 21, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# VA00HKG, 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 EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD HER DEVICE REPROGRAMMED BUT SHE WAS WETTING ALL THE TIME. THE REPORTER INDICATED THAT THE PATIENT HAD AN INFECTION AND THE PATIENT'S HEALTHCARE PROVIDER (HCP) 'WAS TAKING CARE OF THE INFECTION' AND SHE HAD BEEN PUT ON MEDICATION FOR IT. THE REPORTER ALSO STATED THAT THE DEVICE 'NEVER WORKED' AND THE PATIENT HAD ACCIDENTS 'ALL THE TIME.' IT WAS NOTED THAT THE PATIENT HAD REPROGRAMMING DONE AT HER APPOINTMENT WITH HER HCP ON FRIDAY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55980 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention