BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4192834 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20167
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    September 29, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA0E0WN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WENT TO THE DOCTOR ABOUT THREE OR FOUR WEEKS PRIOR TO THE REPORT BECAUSE SHE WASN¿T FEELING STIMULATION AND HAD A RETURN OF SYMPTOMS. SHE MET WITH A MANUFACTURER REPRESENTATIVE WHO TOLD HER THAT THE DEVICE WAS NOT WORKING AND THE MACHINE WASN¿T ON. THE MANUFACTURER REPRESENTATIVE TURNED IT BACK ON AND IT WAS WORKING FINE FOR ABOUT A WEEK. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CONTROLLING HER SYMPTOMS AND SHE WAS FEELING STIMULATION, BUT AFTER A WEEK SHE WASN¿T FEELING STIMULATION AND HER SYMPTOMS GRADUALLY RETURNED. THE PATIENT THOUGHT STIMULATION HAD BEEN TURNED OFF AGAIN AND SHE WASN¿T SURE HOW THE INS WAS BEING TURNED OFF BECAUSE SHE WASN¿T TURNING IT OFF. THERE WERE NO FALLS OR TRAUMA. THE DAY OF THE REPORT THE PATIENT TRIED TO CHECK THE INS, BUT THE PROGRAMMER WOULDN¿T TURN ON OR POWER UP. THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. SHE PUT IN NEW BATTERIES AND STILL NOTHING WAS COMING UP ON THE PROGRAMMER. THE PATIENT TRIED TWO DIFFERENT BRANDS OF BATTERIES AND THEY WEREN¿T WORKING. THE PATIENT HADN¿T DROPPED THE PROGRAMMER OR GOTTEN IT WET. THE NEXT DAY THE PATIENT RECEIVED A NEW PROGRAMMER AND IT WORKED. SHE THOUGHT THE BATTERIES IN HER OLD PROGRAMMER WERE IN THE WRONG WAY BECAUSE WHEN SHE TRIED REPOSITIONING THE BATTERIES THE OLD PROGRAMMER WORKED. THE OLD PROGRAMMER WAS RETURNED TO THE MANUFACTURER. ANALYSIS OF THE PROGRAMMER SHOWED NO SIGNIFICANT ANOMALY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THE PATIENT¿S LOSS OF STIMULATION AND RETURN OF SYMPTOMS. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT PATIENT NEED REPROGRAMMING. THE PATIENT HAD BEEN HAVING TROUBLE WITH HER OLD PATIENT PROGRAMMER AND THE NEW ONE WAS SENT THAT NEEDED TO BE BONDED WITH THE NEUROSTIMULATOR. THE PATIENT NEW PROGRAMMER WAS BONDED TO THE NEUROSTIMULATOR AND WAS NOTED THAT PATIENT WAS GETTING EXCELLENT RESPONSE WITH ALL THE PROGRAMS AT LOW VOLTAGE. IT WAS NOTED PATIENT WAS DOING FAIRLY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670817 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR