BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2220220 · Received August 16, 2011

    Report

    Report Number
    3004209178-2011-06425
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 23, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    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 PT DEVELOPED AN INFECTION AT THE BATTERY SITE SO THE HCP DECIDED TO CREATE A NEW BATTERY SITE AND REPLACE THE BATTERY AS THE HCP WAS CONCERNED THE BATTERY WAS CONTAMINATED. ADD'L 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 59 YR Required Intervention LEAD: MODEL 3093, LOT# V671772| IMPLANTED:| EXPLANTED: