BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1872221 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07952
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 16, 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

    A PT DID NOT HAVE ANY STIMULATION SENSATION REGARDING THEIR LEFT LEAD SINCE THE DEVICE WAS IMPLANTED. A LOW/OUT OF RANGE IMPEDANCE MEASUREMENTS OF <70 OHMS WAS NOTED FOR COMBINATION 0-5. THIS INCLUDED CHANGING THE REFERENCE ELECTRODE. IMPEDANCE READINGS WERE >3600 OHMS/OPEN FOR ALL COMBINATIONS OF #3, #4, AND #7. RIGHT LEAD IMPEDANCE WAS 374 TO 436 OHMS. ALL ELECTRODES WERE PROGRAMMED ON THE RIGHT LEAD. LEFT LEAD IMPEDANCE MEASUREMENT WAS THEN NOTED AS 583 OHMS, AND THE RIGHT BEING 211 OHMS. A COMPANY REPRESENTATIVE ATTEMPTED PROGRAMMING AT 10.5 VOLTS USING #'S 1, 2, AND 6, HOWEVER NO STIMULATION SENSATION OCCURRED. THE PT HAD INDICATED THAT A WIRE WAS STICKING OUT. PER AN IMAGE, KINKING ALONG THE LEAD WAS NOTED. THE PATIENT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA139217N| EXPLANTED| IMPLANTED:| PROGRAMMER: MODEL, 37743, LOT# NKE147147N| IMPLANTED:| LEAD: MODEL 3777, LOT# V416733025| LEAD: MODEL 3777, LOT# V196079005| STIM ACCESSORY: MODEL 37092, LOT# 247590001| IMPLANTED: