BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1961114 · Received January 12, 2011

    Report

    Report Number
    3004209178-2011-00297
    Event Type
    Injury
    Date Received
    January 12, 2011
    Report Date
    December 30, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SEE MANUFACTURER REPORT # 3004209178-2011-00296. IT WAS ORIGINALLY REPORTED THAT THE PT EXPERIENCED A STICKING SENSATION ON HIS RIGHT SHOULDER. HE HEARD A NOISE LIKE A LUMBAR JACK (CHAINSAW NOISES), WHEN TURNING HIS HEAD. HE COULD HEAR THE SOUND WITH HIS STIMULATION ON OR OFF. THE STIMULATION WAS MORE PAINFUL WHEN ON. HIS DEVICE INTERFERED WITH HIS HEARING AID; THEREFORE, HE HAD TO TURN IT OFF. IT WAS LATER REPORTED THE PT DISCUSSED THIS EVENT WITH A COMPANY REPRESENTATIVE. HE HAD SURGERY TO FIX THE PROBLEM WITH HIS DEVICE. HE NO LONGER HAD PROBLEMS WITH HIS DEVICE SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT #: V079506021| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT #: V076403017| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT #: NJD062765N| LEAD: MODEL 3777, LO T#: V076403016| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT #: V079506020| EXPLANTED:| IMPLANTED:| LOT #: NKL704166H| IMPLANTABLE NEURO STIMULATOR: MODEL 37702