BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3222746 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11663
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708340 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708340 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3998 LOT# V013158, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT DID NOT THINK THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS WORKING. IT WAS STATED THE INS HAD NOT BEEN WORKING FOR ABOUT A YEAR OR SO AND THE PATIENT THOUGHT IT HAD BEEN OFF FOR ABOUT A YEAR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322040 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR