BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8842870 · Received July 30, 2019

    Report

    Report Number
    3004209178-2019-14605
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Report Date
    July 30, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287724
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT#: V251861, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #:(B)(4), UBD: 06-MAY-2013, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. THE CALLER WANTED TO KNOW IF THE PATIENT¿S PROGRAMMER COULD BE USED WITH A NEW IMPLANT. IT WAS REPORTED THAT THE PATIENT HAD NOT USED THE DEVICE IN ¿SEVERAL YEARS¿ AS THE WIRE WAS NOT FUNCTIONING. IT WAS NOTED THAT THE PATIENT HAD EXHAUSTED MEDICATIONS AND THE URINARY ISSUES HAD BECOME EXAGGERATED AS THE DEVICE WAS NOW DEAD. IT WAS RECOMMENDED THAT THEY FOLLOW UP WITH THEIR HEALTHCARE PROVIDER FOR DEVICE REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637699 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994287724

    Patients

    Seq Age Sex Outcome Treatment
    1