BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2971379 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02928
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 31, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT# N233471, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INITIALLY THE PATIENT HAD 75% REDUCTION IN PAIN, THEN THE PATIENT HAD AN ACCIDENT ABOUT A YEAR AND A HALF AGO. AFTER THE ACCIDENT THE PAIN RELIEF WAS "LESS AND LESS". IT WAS STATED THAT PATIENT'S HEALTHCARE PROVIDER (HCP) BELIEVED THAT THE IMPACT OF THE ACCIDENT MADE THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM "BREAK, LOOSE, OR MOVE." IT WAS STATED THAT THE PAIN WAS VERY STRONG AND THAT THE PATIENT "COULDN'T HANDLE IT." THREE DAYS PRIOR TO THE REPORT, THE INS WAS REPROGRAMMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A FULL REPLACEMENT OF LEADS AND THE IMPLANTABLE NEUROSTIMULATOR ON (B)(6) 2013. THE REPORTER STATED THAT THE PATIENT HAD DISCHARGED THE DEVICE BATTERY TWICE AND WASN'T GETTING THE COVERAGE IN HER BACK THAT SHE HAD PREVIOUSLY. IT WAS REPORTED THAT FOLLOWING THE REVISION THE PATIENT WAS GETTING GREAT COVERAGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT X-RAYS WERE TAKEN AND IMPEDANCES WERE NORMAL. IT WAS UNCLEAR WHAT THE RESULTS OF THE X-RAYS WERE. HOWEVER, THE REPORTER INDICATED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT WAS REPROGRAMMED 3 TIMES BUT CONTINUED NOT TO HAVE STIMULATION IN THE BACK. A REVISION WAS SCHEDULED FOR (B)(6) 2013. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, ANOTHER FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE/THERAPY BUT WAS WORKING WITH THE COMPANY REPRESENTATIVE. THE PATIENT'S APPOINTMENTS WERE ON (B)(6) 2013. THE DEVICE WAS NOT WORKING RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76858 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