BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 4463014 · Received January 29, 2015

    Report

    Report Number
    3004209178-2015-01388
    Event Type
    Injury
    Date Received
    January 29, 2015
    Date of Event
    January 7, 2015
    Report Date
    January 9, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 389033, LOT# V041096, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD; PRODUCT ID 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED PAIN, SWELLING, AND WARMTH AT THE POCKET SITE OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WHICH OCCURRED 2 DAYS AGO. IT WAS ALSO NOTED THAT THERE WAS A POSSIBLE INFECTION. THE PATIENT HAD NO FALLS OR TRAUMA TO THE AREA. IT WAS LATER CONFIRMED THAT THE PATIENT DID HAVE AN INFECTION AROUND THE INS BATTERY AND THAT THEIR PHYSICIAN WANTED TO REMOVE THE INS AND IMPLANT IT ON THE PATIENT¿S OTHER SIDE. IT WAS REPORTED THAT THE PATIENT DID HAVE GOOD COVERAGE FROM THE INS THERAPY. FOLLOW UP INFORMATION RECEIVED CONFIRMED THAT THE PHYSICIAN REMOVED THE ENTIRE INS SYSTEM AND THAT THE PATIENT WAS TREATED WITH ANTIBIOTICS (BOTH ANAEROBIC AND AEROBIC). THE PATIENT WAS REPORTED AS DOING WELL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67109 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention