BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3643206 · Received February 24, 2014

    Report

    Report Number
    3004209178-2014-03489
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Report Date
    February 19, 2014
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3550-14, LOT# N233166, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6), 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6), 2009, PRODUCT TYPE: LEAD, PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED:(B)(6), 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6), 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37712, SERIAL#(B)(4), IMPLANTED: (B)(6), 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6), 2009-, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS DIABETIC AND APPROXIMATELY TWO YEARS PRIOR THEY DEVELOPED AN ULCER ON THEIR FOOT AND HAD AN OPEN WOUND. THE PATIENT WAS UNABLE TO USE THEIR STIMULATOR BECAUSE WHEN THEY TURNED IT ON THEY HAD EXCRUCIATING PAIN AT THE SITE OF THE WOUND. THE PATIENT HAD TRIED TO KEEP A CHARGE BUT IT HAD DIED MORE THAN ONCE AND IT WOULD NOW NOT KEEP A CHARGE. THE PATIENT NEEDS TO HAVE AN AMPUTATION FROM THE KNEE DOWN ON THEIR LEFT LEG AS A RESULT OF THEIR WOUND AND ALSO NEEDS A KNEE REPLACEMENT. THE PATIENT NEEDS TO HAVE THEIR STIMULATOR REMOVED BECAUSE THEIR CONDITION REQUIRES AN MRI. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTH CARE PROFESSION HAD TO DO A DEBRIDEMENT ON THE WOUND AND THAT IT ¿LEFT A BIG OPEN PLACE.¿ THE REPORTER NOTED THE ¿OTHER PAINS¿ THE PATIENT REPORTED WERE NOT WHAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED FOR. IT WAS ALSO REPORTED THAT AN INS OVERDISCHARGE WAS SUSPECTED. THE REPORTER NOTED THAT THE PATIENT TRIED TO KEEP THE DEVICE CHARGED BUT WAS IN THE HOSPITAL FOR 2.5 MONTHS AND NOW IT WOULDN¿T CHARGE AT ALL. IT WAS NOTED THE PATIENT HADN¿T CHARGED SINCE (B)(6) 2013. TROUBLESHOOTING WAS LIMITED DUE TO THE LACK OF ACCESS TO THE PRODUCT AND/OR PATIENT. IT WAS NOTED THE PATIENT COULD NOT GET ANY COMMUNICATION WITH THE INS. THE REPORTER NOTED THAT THE PATIENT ALREADY HAD THIS TWICE. IT WAS NOTED THE PATIENT WAS ABLE TO RECHARGER HERSELF WITHOUT GOING TO THE HEALTH CARE PROFESSIONAL. THE REPORTER NOTED THE PATIENT HAD AN APPOINTMENT IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112073 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 00050 YR