BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3503563 · Received December 6, 2013

    Report

    Report Number
    3004209178-2013-22075
    Event Type
    Injury
    Date Received
    December 6, 2013
    Report Date
    November 21, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3998 LOT# V082162, IMPLANTED: 2008 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37083-60, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THEIR DEVICE REMOVED BECAUSE IT WAS ¿DEFECTIVE.¿ THE PATIENT STATED THAT THE LEADS MIGRATED AND STARTED TO ¿SHORT CIRCUIT.¿ THE PATIENT STATED THAT THEY WERE GETTING A BURNING SENSATION IN THEIR BACK WHEN THEY TRIED TO ¿CHANGE¿ OR RUN IT. THE PATIENT STATED THEY WOULD CHARGE IT AND WHEN THEY WOULD TURN IT ON IT WOULD BURN THEM. THE PATIENT HAD EXPLTHE DEVICE EXPLANTED. THE PATIENT HAD AN APPOINTMENT WITH THE HEALTHCARE PROFESSIONAL (HCP) UPCOMING ON WEDNESDAY BUT THE PATIENT WAS SICK WITH THE FLU AND WAS NOT GOING TO BE ABLE TO MAKE THE APPOINTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE DEVICE ¿ALMOST KILLED THEM.¿ THE PATIENT REPORTED THAT THE DEVICE ¿WENT DEFECTIVE.¿ THE PATIENT STATED THAT THEY WERE PUT ON MEDICATION ¿HEAVY ENOUGH TO CHOKE A HORSE¿ UNTIL THE DEVICE COULD BE EXPLANTED FROM THEIR BODY AND A NEW ONE IMPLANTED. THE PATIENT NOTED THAT THEY HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS EXPLANTED. THE PATIENT NOTED THAT THEY HAD ALL THE EXPLANTED COMPONENTS ON HAND. THE PATIENT NOTED THAT THE DEVICE WAS EXPLANTED BECAUSE THE LEADS HAD MIGRATED AND STIMULATION WAS SHOCKING THE PATIENT IN THE HIP EVERY TIME THEY WOULD HAVE TO CHARGE. THE PATIENT NOTED THAT AFTER THEY WOULD GET CHARGED UP THEN THEY WOULD START GETTING SHOCKS IN THEIR BACK WHERE IT HAD MIGRATED. IT WAS NOTED THAT THEY GAVE THE PATIENT ¿DUODERM¿ PATCHES TO ALLEVIATE THE ISSUE. THE PATIENT FURTHER NOTED THAT THEY HAD ALL THE X-RAYS ¿AND EVERYTHING.¿ THE PATIENT NOTED THAT THEY HAD TO TAKE INJECTIONS OVER ¿ALL THIS.¿ THE PATIENT NOTED THAT THEY TOOK INJECTIONS EVERY THREE MONTHS AND HAD BEEN GOING ON FOR OVER A YEAR BUT THEN STATED, THE INJECTIONS HAD BEEN GOING ON FOR ¿ALMOST TWO YEARS.¿ THE PATIENT REPORTED THEY FELT ¿BEAUTIFUL¿ WITH THE NEW STIMULATOR THAT WAS IMPLANTED AND THE ¿BEST THAT THEY HAD FELT IN FIVE YEARS.¿ THE PATIENT HAD ALL OF THE DEVICES IN A BIOHAZARD BAG BUT WOULD NOT LET THESE DEVICES OUT OF THEIR HANDS. THE PATIENT STATED THAT THEY COULD PUT IT ON A PLANE AND THEY WOULD SIT WITH THEM WHILE THEY ANALYZED THE DEVICES. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632914 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention