BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1872771 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07987
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD AND EXTENSION "SPUN" IN THE POCKET MULTIPLE TIMES, AND THE LEAD FRACTURED. BOTH THE LEAD AND EXTENSION WERE REPLACED BUT THE EXISTING DEVICE WAS LEFT IN AND TACKED DOWN TO KEEP IT FROM SPINNING IN THE FUTURE. ADDITIONAL INFORMATION RECEIVED INDICATED THE POCKET WAS TOO LARGE AND ALLOWED FOR THE DEVICE TO SPIN IN THE POCKET. FOLLOWING REPLACEMENT, STIMULATION WAS FELT AT A LOW LEVEL AND THE PATIENT WENT HOME WITH IT OPERATING.

    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 57 YR Required Intervention EXTENSION: MODEL 3095, LOT# NAH046125V| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# V386651| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD098338N