BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2260004 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-07159
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT STARTED EXPERIENCING PAIN AT THE IMPLANTABLE NEUROSTIMULATOR SITE, LOWER BACK AND RIGHT LEG APPROXIMATELY 4 WEEKS AGO. THE PT HAD SEEN A CHIROPRACTOR BUT IT WAS RECOMMENDED TO SEE THEIR HEALTHCARE PROVIDER BECAUSE THE DEVICE THERAPY COULD POSSIBLY BE CONTRIBUTING TO THIS PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT # V557258| PROGRAMMER: MODEL 3037, LOT # NJD115322N