BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1872359 · Received October 11, 2010

    Report

    Report Number
    3004209178-2010-07788
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 17, 2010
    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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS FEELING STIMULATION IN THE WRONG LOCATION AFTER A FALL ON (B)(6)2010 IN WHICH THE PT FELL AND HIT HER HEAD. FOLLOWING THE FALL, THE PT HAD BRAIN SCAN MRI'S, AND ON (B)(6)2010, THE PT HAD A SPINAL TAP. AFTER THE SPINAL TAP, THE PT STATED THAT WHEN SHE WENT TO ADJUST HER SETTINGS, SHE FELT STIMULATION IN HER STOMACH "WHERE HER OVARIES ARE." THE PT SAID SHE HAS NEVER FELT THIS BEFORE. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR IMPLANTED:| LEAD: MODEL 3778, LOT# V287762016| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V272521017