BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3262627 · Received August 2, 2013

    Report

    Report Number
    3004209178-2013-12719
    Event Type
    Injury
    Date Received
    August 2, 2013
    Report Date
    July 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(4) 2009, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 399930, LOT # V182611, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BACK SURGERY PERFORMED AND FOLLOWING THE SURGERY THE PATIENT HAD A (B)(6) INFECTION THAT GREW AROUND THE WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIS DEVICE REMOVED DUE TO A STAPH INFECTION IN HIS BACK. ONCE THE PATIENT WAS ¿CLEANED UP,¿ HE WAS ABLE TO GET A NEW DEVICE IMPLANTED. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363569 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 00068 YR Required Intervention