BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2010577 · Received March 1, 2011

    Report

    Report Number
    3004209178-2011-01536
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT WAS EXPERIENCING DIFFICULTIES RECHARGING. PT FEELS THE DEVICE MAY BE TILTED. PT USED THE ANTENNA LOCATE FEATURE AND WAS 46-50, GETTING SIX BARS, BUT IT WOULD GO DOWN TO FOUR AND ZERO. THIS HAS BEEN AN ISSUE SINCE IMPLANT. PT HAS LOST FIVE POUNDS; SHE IS IN SO MUCH PAIN SHE DOES NOT FEEL LIKE EATING. PT SVS WILL F/U WITH THE PT TOMORROW, BUT PT WAS INSTRUCTED TO CONTACT HER HCP. WHEN PT SVS CALLED THE PT BACK, SHE SAID SHE WAS TOO SICK TO DO ANYTHING. SHE THINKS THE INS IS FLIPPED BECAUSE SHE CAN NOT FEEL ALL FOUR CORNERS. SHE IS PLANNING ON SETTING UP AN APPOINTMENT WITH HER HCP AND WOULD LIKE THE MFR'S REP AT HER APPOINTMENT. ADDITIONAL INFO RECEIVED REPORTED THE PT DID SEE HER HCP AND THE INS WAS FOUND TO BE PUSHING THROUGH HER ABDOMEN. SHE WAS SCHEDULED TO HAVE A REVISION. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED A F/U REPORT WILL BE SENT.

    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 56 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE152488N| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB083483V| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB076909V| EXPLANTED:| LEAD: MODEL 3998, LOT# V433773| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC000827V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC001051V| ACCESSORY: MODEL 37752, LOT# NKA143242N