BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1932068 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10026
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    THE DOCTOR WAS GOING TO REPLACE THE NEUROSTIMULATOR (INS) ONLY AND USE THE EXISTING LEAD BUT ENCOUNTERED DIFFICULTY WHILE ADVANCING LEAD INTO THE NEW INS. HE ATTEMPTED TO ADVANCE THE LEAD INTO THE NEW INS BUT COULD NOT GET PASSED THE 3RD OR 4TH CONTACT ON THE 0-7 PORT OF THE INS. A BLUNT 18 GAUGE NEEDLE WAS INSERTED INTO THE 0-7 PORT BUT COULD NOT GET PASSED THE 3RD OR 4TH CONTACT. THE SETSCREW POINT WAS PASSED AND RELEASED THE SETSCREW AS MUCH AS THEY COULD. ATTEMPTED TO RE-INSERT THE SAME EXISTING LEAD TO 8-15 PORT, BUT IT WAS ROUGH GOING IN AND COULD NOT GET THE LEAD TO SEEDED CORRECTLY. THE INS WAS REPLACED AND THE LEAD WENT IN FINE WITHOUT ANY DIFFICULTIES. THE INS WAS GOING TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR LEAD: MODEL 3777, LOT# V010867| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37701| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD027215N| EXPLANTED:| LOT# NKD701040H