BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2223869 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06564
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 1, 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
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT COULD NOT GET ANY STIMULATION. THE DEVICE WAS INTERROGATED AND THE DEVICE SEEMED FINE. THE PT HAD BEEN CHARGING THE DEVICE. THE PT VISITED THEIR HCP IN THE MIDDLE OF (B)(6) 2011 AND X-RAYS WERE TAKEN. THE X-RAYS DID NOT REVEAL ANYTHING OBVIOUS. THE PT HAD A LEAD REPLACEMENT SURGERY ON (B)(6) 2011. THE PT WAS PROGRAMMED POST- OPERATIVELY AND THE PT WAS GETTING GOOD STIMULATION. THE PT WAS SEEN ONE WEEK POST-OPERATIVELY AND EVERYTHING WAS GOING VERY WELL. THE PT REPORTED THEY HAD RECEIVED ASSISTANCE AND THEIR CONCERNS WERE RESOLVED.

    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 IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V349474006| PROGRAMMER: MODEL 37743, LOT# NKE136687N