BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3150752 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08750
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 17, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377745, LOT# N0027894, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 377745, LOT# N0027894, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LEAD REVISION IN 2007. PATIENT OUTCOME WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT FLUOROSCOPIC IMAGING WAS DONE AND IT SHOWED THAT THE PERCUTANEOUS LEADS HAD MIGRATED AND THE PATIENT EXPERIENCED A LACK OF EFFECT. THE CAUSE OF THE MIGRATION WAS UNKNOWN AS THE PATIENT DENIED TRAUMA OR FALLS. THERE WERE NO OTHER VISIBLE ISSUES SEEN WITH THE LEADS WHEN THEY WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250074 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention