BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3301313 · Received August 21, 2013

    Report

    Report Number
    3004209178-2013-14951
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Report Date
    July 25, 2013
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3093-28, LOT# V181439, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE THERAPY BUT HAD NOT SOUGHT FURTHER HELP. IT WAS NOTED THAT THEY NEEDED TO MAKE AN APPOINTMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN MRI FOR THEIR NECK ABOUT 3-4 MONTHS AGO AND THEY WERE SHOCKED BY THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THE REPORTER STATED THE INS ¿LET HER KNOW IT WAS DOWN BELOW AND IT SHOCK HER A LITTLE BIT.¿ IT WAS NOTED THE PATIENT HAD FORGOTTEN THEIR PATIENT PROGRAMMER AND WAS UNABLE TO TURN THE INS OFF PRIOR TO THE MRI. IT WAS NOTED THE PATIENT WAS ON PROGRAM 2 AT 0.8V. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405392 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR