BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3112265 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07641
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    May 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-56, LOT # V937762, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V937762, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3888-33, LOT # V949384, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V983244, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A POWER ON RESET (POR) CONDITION. IT WAS ADDED THE PATIENT WAS ABLE TO RECHARGE WITH 7 COUPLING BARS BUT WAS UNABLE TO ADJUST STIMULATION. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT RECEIVED ASSISTANCE FROM THEIR MANUFACTURER REPRESENTATIVE AND THE GENTLEMAN WALKED HER THROUGH THE PROBLEM ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213530 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