BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4096188 · Received September 17, 2014

    Report

    Report Number
    3004209178-2014-17181
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Report Date
    August 20, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V841549, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE FELL A WHILE AGO LONGER THAN 6 MONTHS AGO BUT COULD NOT REMEMBER IF THERAPY RELIEF CHANGE AROUND THE SAME TIME. THE PATIENT THOUGHT IT MAYBE THE FALL THAT CHANGED THE THERAPY. THE PATIENT INDICATED THAT PRIOR TO SIX MONTHS AGO SHE WAS GETTING GOOD RELIEF FROM THERAPY. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS ALSO INDICATED THAT PATIENT SPOKE TO SOMEONE AND WAS TOLD TO TRY DIFFERENT PROGRAMS ABOUT SIX MONTHS AGO. SHE HAD TRIED ALL THE PROGRAMS AND THEY ARE NOT PROVIDING RELIEF FOR HER. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575942 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR