BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3221224 · Received July 11, 2013

    Report

    Report Number
    9614453-2013-01475
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 20, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37083-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED CONFIRMED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED DUE THE (B)(6). IT WAS ALSO REPORTED THAT THE PATIENT WAS TREATED FOR 6 WEEKS WITH ANTIBIOTICS (¿(B)(6) AND VENCOMYCINE¿). NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPLANT OF THE PATIENT DEVICE WAS PLANNED DUE TO INFECTION. IT WAS NOTED THAT ANTIBIOTIC WILL BE NECESSARY AND A SURGERY CLEANING OR EXPLANT WAS REQUIRED TO OCCUR ON THE DAY OF THE REPORT. IT WAS FURTHER NOTED THAT THE PATIENT WAS EXPERIENCING A BURNING SENSATION. IT WAS ALSO NOTED THAT THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320131 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention