BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2062845 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02154
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 7, 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 THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS STATED THAT, BEGINNING ON (B)(6) 2011, THE PT FELT A SHOCKING/JOLTING THROUGH HER BODY WHETHER THE DEVICE WAS TURNED ON OR OFF. IT WAS STATED THE "SHOCKING TENDS TO FLARE UP AROUND ELECTRICAL GADGETS." IT WAS STATED THE SENSATION WAS WORSE IN THE HANDS AND LEGS. THE PT WAS AT THEIR CLINIC AND THE HEALTH CARE PROVIDER WAS CONSIDERING REMOVING THE DEVICE. THE REPORTER STATED THERE IS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 64 YR ACCESSORY: MODEL 37752, LOT# NKA141162N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE148462N| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 39565-65, LOT# V448855028