BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1812505 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06149
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    June 11, 2010
    Report Date
    July 19, 2010
    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

    IT WAS REPORTED THE PATIENT HAD SURGERY (B)(6) 2010 FOR REPLACEMENT OF SYSTEM, INCLUDING NEW BATTERY AND LEADS. PATIENT REPORTED STILL HAD PROBLEMS WITH THEIR DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.

    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 76 YR Required Intervention EXPLANTED:| LEAD: MODEL 3093, LOT#V015079| PROGRAMMER: MODEL 3037, LOT#NJD036527N| EXPLANTED:| IMPLANTED:| IMPLANTED: