BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2101685 · Received May 10, 2011

    Report

    Report Number
    3004209178-2011-03361
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 LOSS OF THERAPEUTIC EFFECT "THREE DAYS AGO"; THE PATIENT FELT A PULLING OF HIS ARM TOWARD HIS CHEST. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE MFR. REPORT #3004209178201103362 REGARDING THE PATIENT'S OTHER DEVICE SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR PROGRAMMER: MODEL 7438, NHL013361P| LEAD: MODEL 3387, LOT# J0519210V| EXTENSION: MODEL 7482, LOT# NHU085909V| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LOT# NFW160338H| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU085910V| LEAD: MODEL 3387, LOT# J0519210V