BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2231106 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06920
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 12, 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED PAIN OF THE IMPLANT SITE AND A LOSS OF THERAPEUTIC EFFECT AFTER SETTINGS WERE CHANGED. A URINARY TRACT INFECTION, WHICH WAS TREATED BY A HCP, WAS ALSO REPORTED. THE PT REPORTED NEVER BEING REPROGRAMMED. THE PT REPORTED URINATING EVERY HOUR DURING THE DAY AND 3-4 TIMES AT NIGHT. THE PT WAS INSTRUCTED TO TURN THE DEVICE OFF AND CALL THE MANUFACTURER'S REPRESENTATIVE FOR AN APPOINTMENT. THE PT MAY NEED ANOTHER PT PROGRAMMER. THE PT STILL HAD CONCERNS WITH THEIR DEVICE, BUT HAD NOT SOUGHT FURTHER HELP. 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 EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention LEAD: MODEL 3889, LOT# V001085| EXTENSION: MODEL 3095, LOT# NAH026570V| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD114868N| EXPLANTED: