BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4703783 · Received April 17, 2015

    Report

    Report Number
    3004209178-2015-07463
    Event Type
    Malfunction
    Date Received
    April 17, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 27, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-33, LOT# J0104161V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 74001, LOT# N211076, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37092, LOT# 293780002, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING/JOLTING SENSATION. THE PATIENT WAS UNABLE TO MEET WITH THE MANUFACTURER REPRESENTATIVE (REP) THE DAY OF THIS REPORT AND SHE HAD RECENTLY BEEN DIAGNOSED WITH BREAST CANCER AND HAD SEVERAL APPOINTMENTS THE FOLLOWING WEEK. THE PATIENT WAS GOING TO CALL WHEN SHE COULD SCHEDULE A MEETING TO CHECK THE STIMULATOR. THE PATIENT DENIED A FALL. SHE WAS LYING ON THE FLOOR AND REACHED FOR SOMETHING NEAR HER. AFTER THAT, THE STIMULATOR STARTED SHOCKING HER. SHE WAS NOT GETTING STIMULATION AS SHE HAD PREVIOUSLY. SHE WAS ADVISED TO TURN STIMULATION OFF UNTIL WE COULD MEET. THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REP HAD MET WITH THE PATIENT ON (B)(6) 2015. THE SHOCKING SENSATION WAS GONE BUT SHE FELT THE STIMULATION PATTERN HAD CHANGED. SHE HAD BEEN USING THE DEVICE. AN IMPEDANCE CHECK WAS PERFORMED AND ALL WERE WITHIN NORMAL RANGE. THE PATIENT WAS REPROGRAMMED AND 2 NEW PROGRAMS WERE PROVIDED THAT COVERED THE PAIN AREAS. THE PATIENT WAS GETTING EFFECTIVE THERAPY. NO FOLLOW-UP WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257890 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR