BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2043191 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02319
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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

    IT WAS REPORTED THERE WERE LOW IMPEDANCES. THE RIGHT STIMULATOR ELECTRODE 0/3 HAD AN IMPEDANCE READING OF <50 OHMS WITH A CURRENT OF 277 UA. THE IMPEDANCE READING WAS 221 OHMS WITH A CURRENT OF 373 UA. THE PT HAD FALLEN AND LANDED ON THE LEFT SHOULDER. THE PT WAS IN THE HOSPITAL AS A RESULT OF THE FALL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE PT HAS 2 STIMULATORS. IT IS UNCLEAR WHICH STIMULATOR HAS THE LOW IMPEDANCES, SO A REPORT HAS BEEN FILED ON BOTH. SEE MFR REPORT 3004209178-2011-02320 FOR THE OTHER REPORT.

    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 70 YR EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| LEAD: MODEL 3387, LOT# V002332| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU118201V| PROGRAMMER: MODEL 7438, LOT# NHL016622P| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU115041V| LOT# NFW156905H| IMPLANTED:| LEAD: MODEL 3387, LOT# V002332| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED: