BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3912747 · Received July 3, 2014

    Report

    Report Number
    9614453-2014-01528
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 11, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A JOLT WHILE SITTING IN A HOTEL ROOM. THE PATIENT WAS UNSURE IF IT WAS HER SPINE OR THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT TURNED THE INS OFF AND THE ISSUE WENT AWAY. THE INCIDENT HAPPENED TWICE WHILE IN THE HOTEL ROOM WITH NO OTHER EQUIPMENT AROUND. IT WAS ALSO SAID TO HAVE HAPPENED ONCE WHEN THE PATIENT WAS GETTING HER NAILS DONE. THE SHOCKING WAS SAID TO HAVE STARTED IN (B)(6) 2014. THE REPORTER STATED THAT MANUFACTURER REPRESENTATIVE DID NOT THINK THE ISSUE WAS POSITION RELATED, EVEN THOUGH THE SHOCKS OCCURRED WHILE SITTING. THE PATIENT ALSO MENTIONED BEING SORE AND FELT STIMULATION ANTERIOR TO THE ANUS; HOWEVER, THE JOLT WAS MORE TOWARD THE TAILBONE OR INS. THE PATIENT WAS CURRENTLY SET AT C+, 1- AT 3.0 VOLTS. THE PATIENT DENIED ANY FALLS OR TRAUMA ASSOCIATED WITH THE EVENT. IMPEDANCES WERE TESTED AND WERE UNREMARKABLE (SEE RESULTS BELOW). THE REPORTER WAS TO TRY BIPOLAR PROGRAMMING TO SEE IF PATIENT COULD USE A LOWER AMPLITUDE. IT WAS ALSO REPORTED THEN WHEN THE MANUFACTURER REPRESENTATIVE INTERROGATED THE INS TODAY WITH THE CLINICIAN PROGRAMMER, A MESSAGE WAS RECEIVED STATING THAT THE INS WAS PROGRAMMED BY AN INCOMPATIBLE PROGRAMMER. THE MANUFACTURER REPRESENTATIVE THEN WENT AHEAD AND PROGRAMMED THE INS. IT WAS STATED THAT THE INS HAD NOT BEEN INTERROGATED SINCE IMPLANT APPROXIMATELY 7 YEARS AGO. IT WAS DISCUSSED THAT THE ERROR MAY BE DUE TO THE USE OF A DIFFERENT DATA CARD SINCE THE LAST INTERROGATION. IT WAS ALSO STATED THAT THE PATIENT PROGRAMMER SHOWED A LOW BATTERY, BUT THE CLINICIAN PROGRAMMER SHOWED A LONGEVITY OF 102 MONTHS FROM THE DATE OF IMPLANT. AFTER THIS, THE PATIENT PROGRAMMER BATTERY WAS OK. IT WAS NOTED THAT THE PATIENT KEPT THE INS OFF FOR MOST OF THE DAY. THE PATIENT USED THERAPY FOR 30 MINUTES, 3 TIMES A DAY AND HAD DONE SO SINCE IMPLANT. [IMPEDANCE TESTING (ALL RESULTS ARE IN OHMS): C/0= 616, C/1=556, C/2=556, C/3=1111, 0/1=1111, 0/2=1111, 0/3=1111, 1/3-1111, 1/3=1111, 2/3=1111 AND 1/2=1077; THE IMPEDANCE WAS RETESTED AT 2.0 VOLTS AND PULSE WIDTH OF 330 MICROSECONDS: C/0= 724, C/1=691, C/2=691, C/3=872, 0/1=872, 0/2=1171, 0/3=1184, AND 1/2=865, 1/3=1171, AND 2/3=872] IT WAS REPORTED 6 DAYS LATER THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS SUSPECTED THAT THE UNIPOLAR VECTOR MIGHT BE THE SOURCE (USING A UNIPOLAR ELECTRODE COMBINATION), BUT IT WOULD INVESTIGATED FURTHER AT THE NEXT VISIT. IT WAS STATED THAT THERAPY WAS EXPECTED TO BE OK AS A BIPOLAR VECTOR INDICATED APPROPRIATE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389614 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 3023

    Patients

    Seq Age Sex Outcome Treatment
    1