BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1193432 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06372
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT STUMBLED AND FELL APPROXIMATELY 3 WEEKS AGO. THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT. IMPEDANCE MEASUREMENTS WERE CHECKED. READINGS OF >2000 OHMS WERE FOUND ON ALL OR SOME OF THE UNIPOLAR PAIRS; <12 MICROAMPS ON ALL BIPOLARS AND ALL UNIPOLARS EXCEPT C, 2 AND C,3. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOWUP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE MANUFACTURER'S REPORT # 3004209178-2008-06373.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention LEAD: MODEL 3389| EXPLANTED:| EXTENSION: MODEL 7482| LEAD: MODEL 3389| EXTENSION: MODEL 7482| LOT #NFW150585H| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| EXPLANTED:| EXPLANTED: