BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3081118 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06968
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 23, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH THE COUPLING CHANGING WITH SLIGHT MOVEMENT. IT WAS NOTED THAT THE PATIENT COULD GET 8 BARS BUT THEN IT WOULD CHANGE TO ZERO BARS. IT WAS FURTHER NOTED THAT THE DEVICE DOES MOVE SOME IN THE POCKET. THE PATIENT HAS REPORTEDLY HAD 3 DIFFERENT RECHARGERS AND THE PROBLEM HAS PERSISTED WITH EACH ONE. THE PATIENT WAS ALSO REPORTEDLY USING THE RECHARGE BELT AND BINDER TO STABILIZE THE DEVICE DURING RECHARGING AND THE PATIENT WAS RECHARGING AT NIGHT WHILE SLEEPING. IT WAS NOTED THAT WHILE SITTING IN A CHARGE AND RECHARGING USING THE BELT THERE WAS A LOT OF VARIANCE IN COUPLING WITH SLIGHT MOVEMENT. EVEN HOLDING THE RECHARGE TO THE DEVICE WAS SHOWING CHANGES IN COUPLING. IT WAS LATER REPORTED THAT THE CORD ON THE RECHARGER MAY HAVE BEEN BAD. IT WAS ALSO NOTED THAT THERE MAY BE A POSSIBLE POCKET REVISION. IT WAS LATER REPORTED THAT THE DEVICE WORKED FOR THE PATIENT FOR 2-3 MONTHS AND THEN SHE BEGAN HAVING ISSUES WITH RECHARGING. IT WAS NOTED THAT THE PATIENT WOULD START WITH 8 COUPLING BARS AND EVERY TIME SHE MOVED SHE GOT NO BARS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD PUT IT ON AT 8 PM AND WAS GOING TO BED AT 10PM AND EVERY TIME SHE LOOKED AT THE RECHARGER IT WAS OFF. THE PATIENT PUT THE ANTENNA UP TO HER DEVICE AND WAS ABLE TO GET 6 BARS. AN ANTENNA LOCATE FEATURE WAS REPORTEDLY DONE AND THE PATIENT WAS ABLE TO GET 8 BOXES. THE PATIENT REPORTEDLY HAS AN APPOINTMENT TO SEE HER HEALTH CARE PROVIDER (HCP) ON (B)(6) 2013 AND WOULD LIKE TO HAVE A MANUFACTURER REPRESENTATIVE GO OVER RECHARGING. IT WAS THEN REPORTED THAT REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR MANUFACTURE REPRESENTATIVE. IT WAS ALSO NOTED THAT THE PATIENT HAD TOLD THEIR DOCTOR THAT THE DEVICE DOES NOT WORK 2/3 OF THE TIME AND THAT EVERY TIME THE PATIENT PUT IT ON AND MOVE A ½ INCH IT GOES OFF. IT WAS FURTHER NOTED THAT THE PATIENT WAS VERY UNHAPPY WITH THE DEVICE AND STATED THAT THEY WERE HAVING TROUBLE WITH THE DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT WAS HAVING TROUBLE WITH THE 'STRAP.' IT WAS NOTED THAT IT 'WAS THE WORST FOR KEEPING IT ON YOUR WAIST; ALL I HAVE TO DO IS TURN A LITTLE BIT AND THE BUCKLE COMES OFF.' THE PATIENT REPORTEDLY HAS TO USE AN ADDITIONAL STRAP AND IT STILL WOULD NOT WORK. IT WAS NOTED THAT IT WAS NOT DOING WHAT IT SHOULD. IT WAS FURTHER NOTED THAT THE PATIENT HAD THE DEVICE MOVED WHEN THEY HAD BACK SURGERY ON (B)(6) 2013, 'HOPING IT WOULD BE STATIONARY IN THE PATIENT'S BACK BUT IT WASN'T.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180998 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 Required Intervention