BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3130678 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08206
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3889-28 LOT# V639997, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS THE PATIENT¿S FIRST DEVICE AND IT NEVER GAVE HER THERAPEUTIC BENEFIT. THE DEVICE WAS REPLACED BECAUSE ¿THEY THOUGHT IT COULD HAVE BEEN BAD PLACEMENT.¿ HOWEVER, IT WAS UNCLEAR WHEN THE DEVICE WAS REMOVED BECAUSE THE PATIENT STATED BOTH THAT IT WAS REMOVED WHEN THE SECOND DEVICE WAS PLACED AND ¿BOTH NEUROSTIMULATOR AND LEADS¿ WERE EXPLANTED ON (B)(6) 2013. ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2011. THE PATIENT HAD ¿OBJECTIVE SUCCESS¿ AND WENT FOR A SECOND OPINION. NO FURTHER INFORMATION WAS KNOWN. TWO DAYS LATER IT WAS REPORTED THAT THE DEVICE ¿DID NOT WORK.¿ THE PATIENT¿S ISSUES WERE ¿NOT RESOLVED¿ AND SHE HAD THE SYSTEM REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231371 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention