BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2911753 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00495
    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 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LEAD REVISION SURGERY BECAUSE, THE LEADS MOVED AND THE PATIENT WAS NOT GETTING STIMULATION WHERE SHE NEEDED IT. IT WAS STATED THAT THE PATIENT "HAD THE SURGERY TWICE FOR THE IMPLANT". IT WAS UNCLEAR IF THAT STATEMENT MEANT SHE HAD TWO REVISION SURGERIES, OR IF SHE HAD AN IMPLANT SURGERY AND A LEAD REVISION SURGERY. IT WAS ALSO UNCLEAR IF THIS REVISION WAS THE FIRST OR SECOND. 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. REFER TO MANUFACTURER REPORT # 3004209178-2013-00493, FOR INFORMATION ON THE POSSIBLE SECOND REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16885 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