BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2060953 · Received March 14, 2011

    Report

    Report Number
    3004209178-2011-01907
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 28, 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
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION AND ALSO A FALL. IT IS UNCLEAR IF THE SHOCKING WAS OCCURRING PRIOR TO THE FALL. PATIENT STATES SHE IS IN WORSE PAIN SINCE THE FALL. SHE WAS REPROGRAMMED AFTER THE FALL BUT ONLY WAS GIVEN TWO GROUPS, ONE FOR EACH LEG. SHE ALSO REPORTS GETTING "ZINGS" DOWN HER BACK. UNABLE TO COORDINATE TIMELINE OF FALL; REPROGRAMMING AND SYMPTOMS REPORTED. PATIENT IS ASKING TO HAVE A MANUFACTURER'S REPRESENTATIVE MEET WITH HER FOR FURTHER REPROGRAMMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    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 31 YR IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE160886N| EXPLANTED:| LEAD: MODEL 39565-65, LOT# V540964023