BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4513154 · Received February 12, 2015

    Report

    Report Number
    3004209178-2015-02934
    Event Type
    Injury
    Date Received
    February 12, 2015
    Report Date
    January 23, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS FOR INS (B)(4) REVEALED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3550-29, LOT# N250553, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANT WAS MOVED TODAY BECAUSE IT INTERFERED WITH HIS ACTIVITY AND THE BATTERY PACK WAS UNCOMFORTABLE. IT WAS LATER REPORTED THAT THERE WAS NO 50% OR GREATER SYMPTOM REDUCTION. IT WAS NOT WORKING FOR HIM ANY LONGER AND THAT HIS PAIN HAD GONE AWAY BECAUSE HE HAD BEEN MORE ACTIVE. THE PATIENT DID NOT FEEL HE NEEDED THE DEVICE ANY LONGER SO NO TROUBLESHOOTING WAS DONE. THE PATIENT WAS DOING WELL AND RECOVERING FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106595 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