BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1893221 · Received November 2, 2010

    Report

    Report Number
    3004209178-2010-08763
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 8, 2010
    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 THE PT HAD PAIN AND SWELLING AROUND THE SITE OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND INTO THEIR LEGS. IT WAS STATED THE PAIN STARTED TWO AND A HALF WEEKS BEFORE THE REPORT AND LASTED FOR FOUR DAYS, AND THEN SYMPTOMS RETURNED DAYS PRIOR TO THE REPORT. IT WAS STATED THE PT HAD "GONE THROUGH THE SECURITY GATES AT (B)(6) AND REPORTED FEELING AN INCREASE IN STIMULATION AND PAIN A COUPLE OF DAYS LATER." IT WAS ALSO STATED THE PT'S NEW HEALTH CARE PROVIDER DISCUSSED THE POSSIBILITY OF AN INFECTION WITH THE PT. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 39 YR LEAD: MODEL 3889, LOT #V230971| PROGRAMMER: MODEL 3037, LOT #NJD088405N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: