BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2230739 · Received August 23, 2011

    Report

    Report Number
    3004209178-2011-06740
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS DONE ON (B)(6) 2011. DURING THE REVISION, ONE OF THE LEADS HAD AN OUT OF RANGE IMPEDANCE AND WAS REPLACED. THE IMPEDANCE WAS HIGH AND STIMULATION WAS NOT FELT USING THAT LEAD. A NEW LEAD WAS PLACED AND THE PT HAD STIMULATION. AN ASPIRATION OF SEROMA WAS REPORTED ON (B)(6) 2011. THE SEROMA WAS TO THE INCISIONS AND THERE WAS FLUID SWELLING AT THE UPPER TWO LUMBAR INCISIONS AND THE LEFT FLANK INCISION OVER THE NEUROELECTRODE CONNECTION SITE. THE EVENT WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB013256N| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V137815| IMPLANTED:| LEAD: MODEL 3487A, LOT# V083355| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V137815| IMPLANTED:| LEAD: MODEL 3487A, LOT# V083355| ACCESSORY: MODEL 37752, LOT# NKA111502N| EXTENSION: MODEL 37082, LOT# NKB008783N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE122180N| IMPLANTED:| EXPLANTED:| EXPLANTED: