BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2911770 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00493
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 21, 2012
    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

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY OF THE LEADS AND THE IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2012. IT WAS STATED THAT THE LEADS WERE REPOSITIONED, AND THE INS WAS "PUT DEEPER INTO THE SKIN BECAUSE IT SURFACED FROM FIRST SURGERY AND IT WAS POPPING OUT". IT WAS REPORTED THAT THE PATIENT HAS HAD 8 BACK SURGERIES AND THE DOCTOR "WENT BACK IN THROUGH THE ORIGINAL SCAR AND WAS ABLE TO PUT IT UP HIGHER AT THE SECOND REVISION". THE PATIENT STATED THAT THEY HAVE HAD SURGERY TWICE FOR THE IMPLANT. IT WAS UNCLEAR IF THAT STATEMENT MEANT THERE WERE TWO REVISION SURGERIES OR AN IMPLANT AND A REVISION SURGERY. IT WAS ALSO UNCLEAR IF THIS REVISION WAS THE FIRST OR SECOND REVISION. THE PATIENT STATED THAT SHE WAS "DOING WELL" AFTER THE SECOND REVISION UP UNTIL (B)(6) 2012. IT WAS NOTED THAT THE PATIENT HAD TWO FOLLOW UP VISITS WITH THE IMPLANTING PHYSICIAN AND WAS TOLD THAT SHE DIDN'T NEED TO SEE HIM ANYMORE UNLESS THERE WERE ISSUES. APPROXIMATELY TWO WEEKS LATER IT WAS REPORTED THAT THE PATIENT STILL HAD CONCERNS ABOUT THEIR DEVICE OR THERAPY. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013 TO MEET WITH THEIR DOCTOR OR COMPANY REPRESENTATIVE. NO FURTHER INFORMATION ABOUT THIS EVENT WAS PROVIDED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17635 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention