BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3181726 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10686
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    October 1, 2011
    Report Date
    June 24, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-30 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON 2011 (B)(6) THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT HAD BACK AND LEG PAIN, BUT STIMULATION WAS ONLY FELT IN THE LEG AREA AND DID NOT COVER HIS PAIN. THE PATIENT ALSO REPORTED A BURNING SENSATION WHEN SITTING. ADDITIONAL INFORMATION RECEIVED 2011 (B)(6) INDICATED, THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR DOCTOR OR A COMPANY REPRESENTATIVE. THE PATIENT HAD A DOCTOR APPOINTMENT SCHEDULED FOR 2011 (B)(6). INFORMATION RECEIVED 2013 (B)(6) INDICATED, THE PATIENT CONTINUED TO EXPERIENCE THE BURNING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR SITE, SO THE DECISION WAS MADE TO REPLACE THE PATIENT¿S SYSTEM. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282143 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention