BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2465135 · Received February 23, 2012

    Report

    Report Number
    3004209178-2012-01162
    Event Type
    Injury
    Date Received
    February 23, 2012
    Report Date
    February 6, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3888-33, LOT #V011019, IMPLANTED: (B)(6) 2006, EXPLANTED: NA, BOOT/PLUG ACCESSORY MODEL 3550-09, LOT # N083630, (B)(6) 2006 EXPLANTED: NA, POCKET ADPATOR ACCESSORY: MODEL 74001, LOT #N210419, IMPLANTED: (B)(6) 2009, EXPLANTED: NA, PROGRAMMER MODEL 37743, SERIAL # (B)(4), RECHARGER MODEL 37752, SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POCKET REVISION 15 MONTHS AGO DUE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) MOVING IN THE POCKET. IT WAS NOW NOTED THAT THE INS WAS MOVING AGAIN IN THE POCKET. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED INDICATED THAT THE INS WAS BOTHERSOME IN THE ABDOMINAL LOCATION AND DESIRED TO HAVE IT MOVED TO THE REAR. THE PATIENT WAS NOTED TO BE ON A WAITING LIST FOR FURTHER INTERVENTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention