BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3133684 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08230
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28 LOT# V241705, IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. NO HOSPITALIZATION WAS REPORTED AND THE PATIENT OUTCOME WAS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS REPLACED. THE REPORTER THOUGHT THE PATIENT ¿BROKE IT WHEN SHE FELL.¿ IT WAS NOT KNOWN WHEN THE PATIENT FELL. THE REPORTER ASSUMED IT WAS THE FALL BUT IT WAS ALSO ¿GETTING CLOSE TO HAVING TO REPLACE THE DEVICE DUE TO BATTERY DEPLETION.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234289 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention