BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2983597 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03182
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 12, 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
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S "SYSTEM WAS NOT WORKING." IT WAS NOTED THAT THE PATIENT HAD BEEN SEEN BY THE HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2013. IT WAS UNKNOWN HOW LONG THE "DEVICE HAD NOT BEEN WORKING FOR." IT WAS NOTED THAT THE PATIENT WAS "GETTING NOTHING FROM IT" AND WAS UNABLE TO FEEL STIMULATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85658 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1