BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2982397 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03136
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    May 29, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID: 37746, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3550-29, LOT#: N343238, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS DOING WELL AFTER INS REPLACEMENT AND RECEIVING THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) DISPLAYED AN END OF SERVICE/END OF LIFE MESSAGE. AT THE TIME OF INITIAL REPORT, IT WAS REPORTED THAT PATIENT WAS "NO LONGER RECEIVING THERAPY". IT WAS REPORTED THAT THE INS DEPLETION WAS "NORMAL" BASED ON THE PATIENT'S SETTINGS. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED "GOOD THERAPY" UNTIL THE END OF SERVICE MESSAGE OCCURRED. IMPEDANCE TEST VALUES INDICATED IMPEDANCES THAT WERE LESS THAN THE NORMAL RANGE. FURTHER INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86091 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention