BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3023206 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04291
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 399930 LOT# V013836, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 399930, LOT# V013836, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT HIS POCKET SITE. IT WAS FURTHER REPORTED THAT "ANTIBIOTIC TREATMENT WAS NECESSARY." IT WAS STATED THAT THE INFECTION OCCURRED "APPROXIMATELY TWO YEARS" PRIOR TO REPORT. IT WAS ADDITIONALLY STATED THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO THE INFECTION. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT INFECTION WAS FOUND DURING THE PROCEDURE TO REPLACE THE IMPLANTABLE NEUROSTIMULATOR (INS) BECAUSE THE PATIENT WAS TO GET ANOTHER MANUFACTURER¿S DEVICE. DURING THE PROCEDURE, THE INFECTION WAS FOUND AND THE ENTIRE INS SYSTEM WAS REMOVED. IT WAS NOTED THAT NOTHING ELSE WAS IMPLANTED INTO THE PATIENT. THE PATIENT STATUS WAS REPORTED AS ALIVE WITH NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126147 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention