BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2922551 · Received January 18, 2013

    Report

    Report Number
    3004209178-2013-00758
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 31, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT AND A LOSS OF STIMULATION SENSATION. IT WAS NOTED WHEN THE PATIENT WENT TO BED THE NIGHT OF (B)(6), 2012 STIMULATION WAS WORKING AND WHEN THE PATIENT WOKE UP THEY NO LONGER FELT STIMULATION. THE PATIENT DID NOT RECALL ANY FALLS OR TRAUMAS THAT COULD BE RELATED. IT WAS NOTED THE RECHARGER REPORTED FULL BATTERY AND STIMULATION WAS ON AT 4.5 VOLTS. THE PATIENT TURNED STIMULATION UP TO 5.0 VOLTS WHICH WAS NOTED AS 'PREVIOUSLY TOO STRONG' AND THE PATIENT STILL DID NOT FEEL STIMULATION. LEAD CONNECTION CHECK REPORTED '5 OKAY.' IT WAS NOTED ONE OF THE LEADS HAD NEVER WORKED SO '5 OF 8 NEIGHBORING ELECTRODES PAIRS WERE OKAY.' ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT ELECTRODES 4-7 WERE "OUT OF RANGE" AND THAT THERE WERE "4 DEAD CONTACTS AT THE BOTTOM." APPROXIMATELY ONE MONTH AGO IT WAS IMPOSSIBLE TO COMMUNICATE OR REPROGRAM THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR AN UNKNOWN REASON. IT WAS DECIDED TO PUT THE PATIENT "ON A TABLE" AND TO TEST THE LEADS VIA "THE SCREENER BOX." ABOUT TWO DAYS AGO IT WAS DETERMINED THE LEADS WERE OUT OF RANGE. THE PATIENT WAS PROGRAMMED TO THESE OUT OF RANGE ELECTRODES SO IT WAS DETERMINED TO BE THE REASON WHY THE PATIENT WAS NOT GETTING THERAPY. THE INS WAS REPLACED BUT IT WAS MENTIONED THAT "THEY PROBABLY DIDN'T NEED TO AS THEY DETERMINED THE LEAD WAS BAD." SEE MANUFACTURER REPORT # 3007566237-2013-00536 ON THE SITUATION AFTER THE INS REPLACEMENT. THE REPORTER MENTIONED THAT PRIOR TO THE LAST PROGRAMMING SESSION THE STIMULATION WAS COMING ON AND OFF. IT WAS UNCLEAR IF THIS REFERRED TO THE REPLACED OR CURRENT INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27246 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention