BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1864455 · Received October 6, 2010

    Report

    Report Number
    3007566237-2010-07645
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LACK OF THERAPEUTIC EFFECT AND LOST EFFICACY. THE PHYSICIAN TESTED, THE IMPEDANCES AND FOUND THEM GREATER THAN 2000 OHMS ON ALL COMBINATIONS. THE LEAD WAS EXPLANTED AND REPLACED. DURING SURGERY, THE LEAD'S OUTER INSULATION LOOKED INTACT, WHILE A SMALL PORTION OF THE INTERNAL CONDUCTORS APPEARED BLACK NEAR THE PROXIMAL END (EXTENSION SIDE). THERE WAS NO INJURY OR DEATH; THE PATIENT WAS NOTED AS DOING WELL. NO FURTHER INFORMATION WAS REQUESTED AT THIS TIME.

    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 Required Intervention EXPLANTED:| LEAD: MODEL 3389, LOT# UNKNOWN| IMPLANTED: