BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2990388 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03346
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3093-33, LOT # V020255, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3031A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE STIMULATION WAS TURNED ON, IT WAS TURNING OFF AND PATIENT'S PROGRAMMER SEEMED TO WORK INTERMITTENTLY. IT WAS STATED THAT THE PATIENT NEEDED TO INCREASE HER AMPLITUDE QUITE A BIT LATELY. IT WAS BELIEVED THAT THESE WERE ALL SIGNS OF HER IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY REACHING THE END OF LIFE ALTHOUGH THIS HAD NOT BEEN CONFIRMED. A BATTERY REPLACEMENT MIGHT BE NEEDED BUT IT WAS STATED THAT THE PATIENT WAS NOT SURE IF SHE WANTED TO GO THROUGH "THAT PAIN" AGAIN. IT WAS STATED THAT THE PATIENT WAS NOT ABLE TO LEAVE HER INS ON ALL THE TIME "BECAUSE IT GOT UNCOMFORTABLE." THIS MIGHT BE DUE TO THE CONTINUAL INCREASING OF THE AMPLITUDE THAT SHE HAD FOUND HERSELF DOING. IT WAS ALSO REPORTED THAT THE CAUSE OF THE EVENT WAS THAT PATIENT PROGRAMMER WOULDN'T RESPOND. THE EVENT WAS ATTRIBUTED TO THE PATIENT PROGRAMMER. IT WAS STATED THAT "THE PATIENT SOMETIMES DID NOT GET ANY RESPONSE FROM HER BOX." IT WAS ALSO NOTED THAT THE PATIENT DID NOT KEEP HER DEVICE ON ALL THE TIME. IN ADDITION, IT WAS REPORTED THAT THE PATIENT WAS NONCOMPLIANT AND WAS TOLD THAT SHE NEEDED TO KEEP HER "BOX" ON AT A LOW AMPLITUDE IF SHE COULDN'T TOLERATE IT SINCE IT MADE HER HAVE LEG AND HIP PAIN. IT WAS NOTED THAT EXPLANTING THE DEVICE WOULD ALSO BE A POSSIBILITY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93421 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1