BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1910092 · Received November 24, 2010

    Report

    Report Number
    3004209178-2010-09946
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 18, 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
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NEVER HAD THERAPEUTIC EFFECT AND THAT SHE HAD FREQUENCY ISSUES. THE PT REPORTED HAVING A BOWEL OBSTRUCTION ON (B)(6) 2010, AND WHILE RECOVERING FROM THAT SHE DEVELOPED BACK PAIN IN THE MIDDLE UPPER RIGHT BACK, AROUND (B)(6) 2010. THE PT EXPERIENCED STIMULATION IN THE BICYCLE SEAT AREA WHEN THE DEVICE WAS ON, AND SAID THAT THE LEAD WIRE, "POPPED UP 2 INCHES FROM THE IMPLANT CREATING A BUMP, LIKE IT'S TRYING TO PUSH THROUGH FOR MONTHS." ADDITIONAL INFO 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 44 YR Female Required Intervention| H| O "SEE H10...."| IMPLANTED:| LEAD: MODEL 3889, LOT# V434032| PROGRAMMER: MODEL 3037, LOT# NJD104609N| IMPLANTED:| LEAD: MODEL 3889, LOT# V434032| PROGRAMMER: MODEL 3037, LOT# NJD104609N