BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1885006 · Received October 20, 2010

    Report

    Report Number
    3004209178-2010-08167
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (B)(6) 2010, THAT THE PT HAD NO STIMULATION SENSATION BUT COULD TURN THE STIMULATION ON AND OFF. THIS STARTED ABOUT TWO MONTHS PRIOR. ON (B)(6) 2010 THE PT REPORTED STIMULATION IN THE WRONG LOCATION. PT STATED HIS LEAD WAS BAD AND WAS ONLY COVERING TOES AND BUTTOCKS AND HE NEEDED STIMULATION IN THE LEFT LEG. PT STATED HE WAS REPROGRAMMED 1.5 MONTHS EARLIER AND WAS TOLD THAT HIS LEAD WAS NOT WORKING. THEY TRIED REPROGRAMMING BUT STILL NOT SUCCESSFUL. CALLER INDICATED THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE LOCATION OF SYMPTOMS WAS AT THE LEAD LOCATION. 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 45 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA112311N| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC014765N| LEAD: MODEL 3887, LOT# V109266