BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4122600 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17820
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    April 30, 2007
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 355029, LOT# N074943, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 377760, LOT# V009544, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(8), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN IMPLANTED IN THE WRONG LOCATION. IT WAS ORIGINALLY IMPLANTED IN THE PATIENT'S BUTTOCK BUT 6 WEEKS POST IMPLANT WHEN THE PATIENT SAT THE INS WAS TOO CLOSE TO THE SPINE/TAILBONE AREA SO IT WAS REVISED AND MOVED 3" OVER TO A MORE "FLESHY AREA" OF THE PATIENT'S BACK. IT WAS NOTED THAT THIS OCCURRED APPROXIMATELY 7 YEARS AGO AND THE PATIENT STATED THAT A MANUFACTURER¿S REPRESENTATIVE WAS PRESENT. FOLLOW UP WITH A MANUFACTURER¿S REPRESENTATIVE WHO REGISTERED THE PATIENT¿S DEVICE REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE COULD REMEMBER THE HEALTHCARE PROFESSIONAL (HCP) AND STATED ¿HE WAS A GOOD PHYSICIAN AND SHE DID ASSIST HIM WITH MANY IMPLANTS.¿ IT WAS STATED THAT THE HCP DID NOT ALWAYS HAVE A MANUFACTURER¿S REPRESENTATIVE PRESENT FOR REVISIONS, ESPECIALLY POCKET REVISIONS AS DESCRIBED IN THIS EVENT. THE MANUFACTURER¿S REPRESENTATIVE STATED THAT SHE HAD NO RECALL OF THE PATIENT NAME OR IF SHE ASSISTED WITH A POCKET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600432 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 00056 YR Required Intervention