BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2161787 · Received July 8, 2011

    Report

    Report Number
    3004209178-2011-05240
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    June 14, 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
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TESTING OF THE RECHARGER (MODEL 37751, SERIAL NUMBER (B)(4)) REVEALED AN OPEN RECHARGE ANTENNA. THE ANTENNA WAS REPLACED.

    Description of Event or Problem · 1

    THE PT HAD A LEAD REVISION IN FEBRUARY AND SINCE THEN HAD EXPERIENCED RECHARGING ISSUES. THE REASON THE REVISION WAS NEEDED WAS NOT PROVIDED. THE PROBLEMS WITH RECHARGE COUPLING LEAD TO AN OVER-DISCHARGE. THE EXTERNAL RECHARGER WAS REPLACED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 40 YR Female Required Intervention ACCESSORY: MODEL 37752, LOT # NKA136185N.| EXPLANTED: | EXPLANTED: | EXTERNAL DEVICE: MODEL 37751, LOT # NKA136189N.| IMPLANTED: | IMPLANTED: | LEAD: MODEL 3777, LOT # V379360029.| LEAD: MODEL 3777, LOT # V379360031.| PROGRAMMER: MODEL 37743, LOT # NKE138104N.| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA136185N| LEAD: MODEL 3777, LOT # V379360029| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT # V379360031| PROGRAMMER: MODEL 37743, LOT # NKE138104N| EXTERNAL DEVICE: MODEL 37751, LOT # NKA136189N| EXPLANTED: