BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2141217 · Received June 22, 2011

    Report

    Report Number
    3004209178-2011-04683
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    February 1, 2011
    Report Date
    May 25, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INITIAL REPORT WAS MADE REGARDING DIFFICULTY IN RECHARGING. ALTHOUGH PATIENT DID GET CLEARANCE TO RECHARGE, IT WAS REPORTED THAT RECHARGING TOOK A LONG TIME. PATIENT REPORTED DEVICE BEING TURNED OFF FOR 3 WEEKS DURING WHICH TIME SHE WAS IN A LOT OF PAIN. REPROGRAMMING EFFORTS WERE DONE ON (B)(6), 2011. PHYSICIAN REPORTED THAT PARESTHESIA WAS IN THE WRONG LOCATION AND THAT PATIENT HAD NEVER RECEIVED OPTIMAL COVERAGE POST-OPERATIVELY WITH THE PERCUTANEOUS LEAD. X-RAYS WERE TAKEN (B)(6), 2011, BUT RESULTS WERE NOT REPORTED. A LEAD REVISION WAS ACCOMPLISHED ON (B)(6), 2011 USING A PADDLE LEAD. REVISION DID NOT REQUIRE HOSPITALIZATION. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    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 58 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3776, LOT # V107555018| IMPLANTED:| LEAD: MODEL 3778, LOT # V607971014| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA149617N| PROGRAMMER: MODEL 37743, LOT # NKE160156N