BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2251127 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07599
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Report Date
    August 17, 2011
    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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INTERMITTENT STIMULATION. THERE WAS NO INCIDENT RELATED TO THE EVENT. IMPEDANCE MEASUREMENTS ON ELECTRODE 8, 10, AND 11 WERE GREATER THAN 3,600 OHMS. THE COMPANY REPRESENTATIVE ATTEMPTED TO PROGRAM AROUND THE IMPEDANCE USING ELECTRODE 9, BUT STIMULATION WAS IN THE WRONG LOCATION AND WAS STILL INTERMITTENT. PALPATION DID NOT CAUSE STIMULATION CHANGES. THE PATIENT DID NOT KEEP THE APPOINTMENT TO HAVE THE DEVICE CHECKED ON (B)(6) 2011. THE REPRESENTATIVE SPOKE WITH THE PHYSICIAN, WHO PLANNED TO SEE THE PATIENT AND POTENTIALLY DO A REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD010128N| ACCESSORY: MODEL 37752, LOT# NKA011400N| EXTENSION: MODEL 37083, LOT# NKC013178N| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC013177N| EXPLANTED:| LEAD: MODEL 3998, LOT# V036156