BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1191184 · Received September 26, 2008

    Report

    Report Number
    3004209178-2008-06167
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 5, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ABOUT SIX WEEKS AGO. ABOUT 10 DAYS PRIOR TO THE REPORT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS SEEN IN THE CLINIC. THERE WAS IMPEDANCE READINGS >2000 OHMS ON SOME OR ALL BIPOLAR PAIRS (PAIRS WERE NOT SPECIFIED). THE PATIENT STATUS WAS REPORTED AS GOOD. THE HEALTHCARE PROVIDER WAS CONSIDERING FURTHER TROUBLESHOOTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 54 YR Required Intervention LEAD: MODEL 3387| EXTENSION: MODEL 7495-51| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXTENSION: MODEL 7495-51| LEAD: MODEL 3387| EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT# NFW135844H| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: