BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2442300 · Received February 8, 2012

    Report

    Report Number
    3004209178-2012-00845
    Event Type
    Injury
    Date Received
    February 8, 2012
    Report Date
    April 9, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3587A, LOT #N0053510, IMPLANTED: (B)(6) 2006, EXPLANTED: NA, EXTENSION MODEL 748966, (B)(4), IMPLANTED: (B)(6) 2006, POCKET ADAPTOR, MODEL 74001, LOT#N240169, IMPLANTED: (B)(6) 2010, EXPLANTED: NA, EXTERNAL ANTENNA MODEL 37092, LOT #249360004, PROGRAMMER MODEL 37743, (B)(4), RECHARGER MODEL 37752, (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT'S CONCERNS WERE RESOLVED DURING A MEETING WITH A MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT HAD NO MORE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RASH OVER THE IMPLANTABLE NEUROSTIMULATOR (INS) WHICH APPEARED AS 25 ITCHY, DEEP, RED SLASH-LIKE HALF INCH 'CAT SCRATCHES'. THE PATIENT WAS GIVEN A STEROID SHOT BY THEIR HEALTHCARE PROFESSIONAL. IT WAS NOTED THAT THE INS SYSTEM WAS WORKING WELL. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention