BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2082783 · Received May 3, 2011

    Report

    Report Number
    3004209178-2011-03222
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO, THE PT'S INCISION WAS DRAINING AND THE PHYSICIAN HAD DONE A WOUND CULTURE. THE CULTURE WAS POSITIVE FOR PSEUDOMONAS INFECTION. PT STATED THE DEVICE WAS WORKING FINE OTHER THAN THE DRAINAGE. THIS IS THE SECOND IMPLANT THE PT HAS HAD AND SHE EXPERIENCED NO PROBLEMS WITH THE FIRST DEVICE. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 H0303476

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention IMPLANTED:| LEAD: MODEL 3093, LOT# V575375| PROGRAMMER: MODEL 3037, LOT# NJD116495N| EXPLANTED: