BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2851685 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10961
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    October 31, 2012
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # (B)(4), PRODUCT TYPE LEAD; PRODUCT ID NEU_ UNKNOWN_LEAD, SERIAL # (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD TO HAVE 4-5 SURGERIES TO GET THE DEVICE PLACED. THE REPORTER STATED THAT THE RIGHT LEAD CAME OUT WHILE THEY WERE TRANSPORTING THE PATIENT ON THE GURNEY. IT WAS REPORTED THAT THE DEVICE WAS PLACED "ON THE FRONT" BECAUSE THE PATIENT HAD AN ARTIFICIAL HIP. THE REPORTER STATED THAT THE DEVICE WAS PLACED UNDER THE RIBS AND IT WAS RUBBING AND CAUSING PAIN. IT WAS REPORTED THAT WHEN THE DEVICE WAS PLACED ON THE LEFT SIDE IT "WORKED OK." 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
    1 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 Required Intervention