BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2210526 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-06225
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011 THAT THE PATIENT HAD COUPLING ISSUES WITH A RECHARGEABLE NEUROSTIMULATOR. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 REPORTED THAT THE PATIENT WAS ORIGINALLY UNHAPPY WITH HOW LONG IT TOOK TO RECHARGE, HOW OFTEN HE HAD TO RECHARGE, AND HAD PROBLEMS KEEPING THE BELT ON. THE PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2011 AND WAS "DOING WELL NOW".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention ACCESSORY: MODEL 37752, LOT# NKA145024N| PROGRAMMER: MODEL 37743, LOT# NKE150440N| LEAD: MODEL 39565-65, LOT# V516902001| IMPLANTED:| EXPLANTED: