BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2120165 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04018
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    December 27, 2010
    Report Date
    May 6, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS "ELECTROCUTED" BY HER FREEZER IN (B)(6) 2010. AFTER THAT, SHE FELT "ELECTRIC DISCHARGES" WHEN SHE TOUCHED METAL AN UNCOMFORTABLE SENSATIONS EVEN WHEN HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF. THE INS WAS EXPLANTED AND NOT REPLACED. THE PT STOPPED EXPERIENCING THE UNCOMFORTABLE SENSATIONS BUT ALSO EXPERIENCED A RETURN OF HER PAIN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL 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 Required Intervention