BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1328988 · Received March 2, 2009

    Report

    Report Number
    6000032-2009-01457
    Event Type
    Injury
    Date Received
    March 2, 2009
    Date of Event
    July 15, 2003
    Report Date
    February 2, 2009
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN EXTENSION AT THE EXTENSION TRACK. THE SYSTEM WAS EXPLANTED. THE PATIENT ALSO UNDERWENT EXPLORATION OF THE CONNECTOR SITE AND DRAINAGE OF AN ABSCESS. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS OF NAFCILLIN 2 GM EVERY 4 HOURS FOR 6 WEEKS AND CEPHALEXIN 500 MG A DAY FOR FOUR WEEKS AFTER THE NAFCILLIN WAS COMPLETED. THE PATIENT RECOVERED WITH SEQUELA (SEQUELA WAS NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO, MED REL 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention EXPLANTED:| EXTENSION: MODEL 7495-51| LEAD: MODEL 3387| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| IMPLANTED:| LOT# NFW100239H| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387| IMPLANTED: