BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2200850 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06152
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A SURGICAL LEAD IMPLANT ON (B)(6) 2011. STIMULATION WAS CHECKED INTRAOPERATIVELY, AND THEN TURNED OFF. FOLLOWING THE IMPLANT, THE PT WAS WALKING AROUND THE HOSP. THE PT REPORTED TO THE HOSP WITH SYMPTOMS OF LEG NUMBNESS AND WEAKNESS. A CT SCAN SHOWED AN EPIDURAL CLOT. THE HEALTH CARE PROVIDER ALSO REPORTED CLOTTING AT THE INS SITE. ALL COMPONENTS OF THE SYSTEM WERE EXPLANTED ON (B)(6) 2011. THE NEUROSTIMULATOR WAS TURNED OFF AT THE TIME OF THE EVENT. THE PT'S STATUS WAS REPORTED AS IMPROVED, BUT WEAK, WITH SOME MOVEMENT IN THE LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention