BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4565023 · Received March 3, 2015

    Report

    Report Number
    3004209178-2015-04031
    Event Type
    Injury
    Date Received
    March 3, 2015
    Report Date
    February 12, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT# J0217219V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-29, LOT# N260112, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WASN¿T USING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO LESS PAIN AND THE INS SITE WAS PAINFUL. REPROGRAMMING WAS PERFORMED. AS A RESULT THE DEVICE WAS EXPLANTED ON (B)(6) 2015. IT WAS UNKNOWN WHAT THE CAUSE OF THE ISSUE WAS OR IT IF THE ISSUE WAS RESOLVED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. AT THE TIME OF THE REPORT THE PATIENT WAS ALIVE WITH NO INJURY. FOLLOWING THE EXPLANT THE PATIENT WAS DOING BETTER WITH THE INS SORENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147024 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