BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3081076 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06966
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3550-29, LOT # N141208, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER RECORDS SHOWED THE DEVICE WAS IMPLANTED AFTER THE USE BY DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS RELEASED TO THE HOSPITAL'S CONSIGNMENT ON 2008 (B)(6). IT WAS NOTED THE INS WAS PULLED FROM CONSIGNMENT FOR A CASE DATED 2008 (B)(6) AND THE MANUFACTURER BILLED THE HOSPITAL FOR THE INS ON 2008 (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182510 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