BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1890977 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-08660
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH RECHARGING. THE PT HAD SWELLING PRESENT FROM AN UNRELATED BACK SURGERY. THE PT HAD TWO IMPLANTABLE NEUROSTIMULATOR (INS) DEVICES, ONE ON EACH HIP. TELEMETRY WAS OK ON THE LEFT HIP. ON THE RIGHT HIP PT GOT 0-2 BARS. THE PT PROGRAMMER WAS WORKING. THE PT REPORTED NO STIMULATION SENSATION. THE PT STATED SHE WAS CURRENTLY IN THE HOSP DUE TO A BACK SURGERY THAT WAS UNRELATED TO DEVICE. PT STATED THAT SHE WAS NOT FEELING THE SENSATION LIKE SHE USED TO AND WONDERED IF IT WAS DUE TO THE SURGERY OR SOMETHING ELSE. THE PT STATED SHE WANTED TO GET IT CHECKED. THE PT PROGRAMMER WAS ON AND SHE WAS ABLE TO INCREASE HER SETTINGS TWICE THE RATE UP AND STILL CAN NOT FEEL IT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT # 3004209178201008658.

    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 70 YR EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37712| EXTENSION: MODEL 37081, LOT# NJB061263V| STIM ACCESSORY: MODEL 3550-39, LOT# N230587| IMPLANTED:| IMPLANTED:| EXPLANTED:| LOT# NKF717246H| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V304327001| PROGRAMMER: MODEL 37743, LOT# NKE127425N| EXPLANTED:| LEAD: MODEL 3777, LOT# V250981005| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE136531N| ACCESSORY: MODEL 37752, LOT# NKA132702N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N184507002| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA124717N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB060949V