BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1191847 · Received October 1, 2008

    Report

    Report Number
    2182207-2008-06255
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD END CAP DAMAGED THE LEAD. IMPEDANCES GREATER THAN 2000 OHMS WERE REPORTED ON ALL OR SOME OF THE UNIPOLAR PAIRS. NO PT SYMPTOMS OR FURTHER DEVICE TROUBLESHOOTING WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL UNK| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK MVD| EXPLANTED: