BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2230435 · Received August 15, 2011

    Report

    Report Number
    3004209178-2011-06342
    Event Type
    Injury
    Date Received
    August 15, 2011
    Report Date
    July 20, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD NEVER RECEIVED THERAPEUTIC EFFECT, DESPITE HAVING UNDERGONE A LEAD REVISION. IT WAS NOTED THAT THE PT'S "RADIATION TREATMENT MUST HAVE DONE MORE DAMAGE THAN SHE HAD THOUGHT." THE PT'S STATUS WAS UNK. 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 Required Intervention PROGRAMMER: MODEL 3037, LOT# NJD061893N| EXPLANTED:| LEAD: MODEL 3889, LOT# V072759| IMPLANTED: