BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2151017 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04618
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL WAS UNABLE TO GET THE IMPLANTABLE NEUROSTIMULATOR (INS) SETSCREW TO TIGHTEN ON THE LEAD DURING IMPLANT. THE TORQUE WRENCH MADE CLICKING NOISES BUT THE LEAD WOULD FALL OUT OF THE INS AND COULD NOT BE SECURED. A NEW INS WAS USED WHICH WAS ABLE TO SECURE THE LEAD. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 62 YR LEAD: MODEL 3093, LOT# V650831| LOT# NJY166665H| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD125159N| STIM ACCESSORY: MODEL WRENCH, LOT# UNKNOWN| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 3058| IMPLANTED: