BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2251086 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07598
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Report Date
    August 16, 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
    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 EXPERIENCED A SHOCKING/JOLTING SENSATION WHEN EXPOSED TO SECURITY DEVICES. NO SPECIFIC INSTANCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    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 EXPLANTED:| LEAD: MODEL 3093, LOT# V360228| PROGRAMMER: MODEL 3037, LOT# NJD087934N| IMPLANTED: