BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3211524 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11462
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 14, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONTINUATION: PRODUCT ID 3889-28, LOT# VA07230, IMPLANTED: (B)(6) 2013: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION. WHEN THE PATIENT TURNED THE DEVICE ON SHE FELT STIMULATION. HOWEVER, WHEN SHE MADE A CHANGE, SHE WAS NOT FEELING STIMULATION. THE PATIENT ONLY FELT STIMULATION WHEN SHE PRESSED THE ON BUTTON, WHEN THE ANTENNA WAS OVER THE DEVICE, AND THEN IT WENT AWAY. THIS HAD BEEN HAPPENING SINCE THE PATIENT WAS IMPLANTED. THE REPORTER INDICATED THAT AT THE PATIENT¿S HEALTHCARE PROVIDER¿S OFFICE, SHE FELT STIMULATION BUT THEN IT FADED AWAY. AT THE TIME OF THE REPORT, THE DEVICE WAS ON, AT AN AMPLITUDE OF 4.5V. IT WAS NOTED THAT THE DEVICE WAS HELPING CONTROL THE PATIENT¿S SYMPTOMS. THE PATIENT INCREASED THE DEVICE TO 8V AND SHE ONLY GOT UP ONCE TO URINATE. OTHER NIGHTS, THE PATIENT¿S SETTING WAS AT A LOWER AMPLITUDE AND SHE WAS GETTING UP TWO TO THREE TIMES. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT¿S BOWEL PROBLEMS CAME BACK AS OF (B)(6) 2013. THE PATIENT HAD TRIED ALL PROGRAMS AVAILABLE AND NONE WERE HELPING HER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A REPROGRAMMING OCCURRED ON (B)(6) 2013 AND RESULTS WERE ¿NOT KNOWN YET¿ BUT THE PATIENT EXPERIENCED A "50% REDUCTION IN INCONTINENCE EVENTS WITH THE PREVIOUS PROGRAM BUT PATIENT ¿WANTED A BETTER RESULT¿. IT WAS NOTED THAT THERE WERE NO ERROR MESSAGES AND A NEW PROGRAM WAS SELECTED. IT WAS FURTHER NOTED THAT THE PATIENT¿S PERCEPTION WAS THAT "NOT FEELING" MEANT "NOT WORKING". IT WAS REPORTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. IT WAS NOTED THAT THE PATIENT¿S OUTCOME WAS NO INJURY AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311227 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR