BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3160035 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10048
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3587A LOT# LC2430, IMPLANTED: 2005 (B)(6), EXPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3708360 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM REMOVED DUE TO INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE DIAGNOSIS OF INFECTION WAS ON (B)(6) 2007. IT WAS NOTED THE PATIENT WAS GIVEN PERIOPERATIVE ANTI BIOTICS AND DID NOT HAVE MENINGITIS. IT WAS FURTHER NOTED THE PATIENT SYMPTOMS WERE SWELLING AND DRAINAGE AT THE DEVICE POCKET. THE REPORTER STATED CULTURES FROM THE DEVICE POCKET WERE TAKEN AND (B)(6) WAS CULTURED. IT WAS NOTED THE SYSTEM WAS EXPLANTED AND THE PATIENT WAS GIVEN INTRAVENOUS AND ORAL ANTIBIOTICS. IT WAS FURTHER REPORTED THE INFECTION RESOLVED AND THE PATIENT HAD THE SYSTEM RE-IMPLANTED IN (B)(6) 2009. IT WAS NOTED THAT THE PATIENT HAD DIABETES PRIOR TO THE IMPLANT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260418 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 00056 YR Required Intervention