BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3003987 · Received March 14, 2013

    Report

    Report Number
    3004209178-2013-03708
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3776-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-56, LOT # V660847, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT # V953746, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INFECTION AT THE SURGICAL SITE. LAB TESTS ON (B)(6) 2013 SHOWED AN ELEVATED WHITE BLOOD COUNT, AND SED (ERYTHROCYTE SEDIMENTATION) RATES AFTER THIS CONTINUED TO BE HIGH. IT WAS REPORTED THAT ETIOLOGY WAS THE IMPLANTABLE NEUROSTIMULATOR POCKET AT THE LUMBAR SITE. IT WAS NOTED THAT ETIOLOGY WAS NOT RELATED TO THE DEVICE OR THERAPY BUT POSSIBLY RELATED TO THE IMPLANT PROCEDURE. SIGNS AND SYMPTOMS INCLUDED REDNESS, SWELLING, DISCHARGE AT THE WOUND SITE, OVERALL DISCOMFORT, AND A PROGRESSION OF THE PATIENT NOT IMPROVING. IT WAS NOTED THAT SEVERITY WAS MODERATE. IT WAS REPORTED THAT THE PATIENT DID NOT RESPOND TO ANTIBIOTICS AND A DECISION TO TAKE OUT THE LUMBAR DEVICE SYSTEM WAS MADE. THE ENTIRE DEVICE SYSTEM WAS EXPLANTED AS AN INTERVENTION ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107751 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention