BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2162076 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-05357
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 17, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT COULD NOT ESTABLISH ANY BARS WHEN ATTEMPTING TO RECHARGE. IT WAS BELIEVED THE IMPLANTED NEUROSTIMULATOR WAS EITHER TOO DEEP OR IT EXPERIENCED A MALFUNCTION. THE PT REQUESTED A NON-RECHARGEABLE DEVICE. THE IMPLANTED NEUROSTIMULATOR WAS EXPLANTED AND REPLACED WITH A NON-RECHARGEABLE UNIT. NO PT INJURY WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 41 YR Required Intervention EXPLANTED:| LEAD: MODEL 3778, LOT# V611801014| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V672832030| ACCESSORY: MODEL 37752, LOT# NKA149126N