BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2102683 · Received May 19, 2011

    Report

    Report Number
    3004209178-2011-03663
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LACK OF THERAPEUTIC EFFECT FOLLOWING ELECTROMAGNETIC INTERFERENCE DUE TO CARDIOVERSION. THE NEUROSTIMULATOR WAS TURNED DOWN AND OFF DURING THE CARDIOVERSION. THE PT'S HEALTH CARE PROFESSIONAL ATTEMPTED TO REPROGRAM THE DEVICE W/O SUCCESS. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE. SEE ALSO MFR'S REPORT #3004209178-2011-03664.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# L47029| EXTENSION: MODEL 7495-51, LOT# XR0046219N| IMPLANTED:| EXTENSION: MODEL 7495-66, LOT# XS0003934N| LEAD: MODEL 3387, LOT# L47030| EXPLANTED:| EXPLANTED:| IMPLANTED:| LOT# NFW156195H| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,