BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1892742 · Received October 28, 2010

    Report

    Report Number
    3004209178-2010-08586
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 1, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT HAD AN INFECTION AT THE SITE OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED, THE PT WAS RECEIVING TREATMENT FOR THE INFECTION FOR NINE DAYS. IT WAS ALSO STATED, THE PT WAS HAVING ISSUES WITH COUPLING AND RECHARGING. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE. REFERENCE MFR REPORT #3004209178-2010-08584.

    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 55 YR Other ACCESSORY: MODEL 37752, LOT# NKA143183N| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37712,| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA143169N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE153073N| LOT# NKF726438H| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB077805V| EXPLANTED:| LEAD: MODEL 39565-65, LOT# V497887039| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V298147024| LEAD: MODEL 3777, LOT# V298147022