BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2082802 · Received May 3, 2011

    Report

    Report Number
    3004209178-2011-03207
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT ADJUST THEIR STIMULATION AND A "CALL YOUR DOCTOR" MESSAGE WAS SEEN ON THE PROGRAMMER. A POWER-ON-RESET (POR) CONDITION WAS ALSO REPORTED, ALL FOLLOWING A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD108242N| LEAD: MODEL 3093, LOT# V475907| IMPLANTED: