BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3100618 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-07402
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 26, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 399960, LOT# V030245, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A LOT OF FALLS, AND THE INS HAD TURNED AND SEEMED FLIPPED IN HER BODY. IT WAS NOTED THAT THIS HAD HAPPENED THREE YEARS AGO, AND THE INS HADN¿T BEEN STICKING OUT AS MUCH, BUT NOT IT WAS MORE. THE PATIENT HAD NOT SEEN HER HCP SINCE 2010. IT WAS ALSO REPORTED THAT THE RECHARGER WAS TAKING LONGER TO CHARGE, BUT IT WAS CHARGING ALL THE WAY UP AND WAS WORKING ALRIGHT. IT WAS NOTED THAT THIS HAD BEEN AN ON-GOING ISSUE AND THE PATIENT STATED THOUGHT HER DEVICE WAS JUST GETTING OLD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE HAD GOTTEN CAUGHT AND MOVED, SO IT WAS REALLY TILTED OUT. THE REPORTER NOTED THE PATIENT WAS TRYING TO SCOOT OUT OF THE CAR AND OUT OF THE SEAT WITH HER ARMS FULL. AS SHE JUST STARTED SCOOTING OVER, THE IMPLANT IN THE BUTT CAUGHT ON THE CURVED END OF THE SEAT. IT WAS NOTED THE PATIENT DIDN'T REALLY FEEL IT OR UNDERSTAND WHAT WAS GOING ON UNTIL IT HURT. SINCE THEN, IT WAS NOTED THE TOP WAS TILTED OUT TO WHERE SHE COULD SEE IT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN APPOINTMENT WITH THE HEALTH CARE PROFESSIONAL IN THE PRIOR WEEK AND THEY HAD CONCERNS ABOUT THE PATIENTS IMPLANTABLE NEUROSTIMULATOR (INS) BECAUSE IT HAD BEEN IN SINCE 2007. IT WAS NOTED THAT IN 2010, THE PATIENT WAS SCOOTING OUT OF HER CAR AND CAUGHT HER IMPLANT. THE REPORTER NOTED THAT THE IMPLANT WAS TILTED OUT OF HER SIDE TO A POINT WHERE IT WAS PAINFUL. IT WAS NOTED THE PATIENT THOUGHT SHE TORE SOME SCAR TISSUE. IT WAS NOTED THAT RECHARGING TOOK A LONG TIME AND WAS PAINFUL. THE REPORTER NOTED THAT IF THE PATIENT WORE THE RECHARGER AROUND, IT LEFT SOME WEIRD BRUISES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT AFTER THE FALL THE PATIENT WAS ¿HURT,¿ LIKE SHE ¿TORE SCAR TISSUE OR SOMETHING.¿ IT WAS NOTED THAT THREE YEARS AGO WHEN THE FALL HAPPENED, THE DEVICE WASN¿T STICKING OUT AS MUCH BUT ¿NOW IT IS.¿ THE PATIENT NOTED THAT THE TOP WAS TILTED OUT. IT WAS NOTED THAT THE PATIENT¿S DEVICE WAS NOT ¿HOLDING A CHARGE AS LONG.¿ IT WAS NOTED THAT THE DEVICE WAS ¿OLDER.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201596 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 00057 YR