BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2161797 · Received July 8, 2011

    Report

    Report Number
    9614453-2011-05224
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING PHYSICAL IMPACT TO HER LEAD. INCREASED IMPEDANCES WERE ALSO OBSERVED ON THE ACTIVE CONTACT (0) FOLLOWING THE IMPACT. THE IMPACT OCCURRED WHEN THE PT STOOD UP AND HIT HER HEAD. IT WAS UNK WHERE SHE HIT HER HEAD OR WHAT SHE HIT IT ON. X-RAY SHOWED NO BREAKS HAD OCCURRED IN THE LEAD OR EXTENSION. THE LEAD-EXTENSION CONNECTION SITE WAS LOCALIZED BEHIND THE PT'S EAR. INTRA-OPERATIVE ASSESSMENT SUGGESTED THE PROBLEM OCCURRED IN EITHER THE EXTENSION OR NEUROSTIMULATOR. BOTH THE EXTENSION AND THE NEUROSTIMULATOR WERE EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention EXTENSION: MODEL 7482, LOT # NHU103299V| IMPLANTED:| EXPLANTED: