BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3961043 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13578
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 778-60, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A CONFIRMED INFECTION. THE DEVICE WAS REMOVED, AS PREVIOUSLY REPORTED, AND SINCE THE PATIENT HAS BEEN RECEIVING EPIDURALS FOR THEIR LEG AND BACK PAIN. THE PATIENT WAS ALSO PLACED ON MEDICATION AND WOULD NOT BE RECEIVING ANOTHER IMPLANT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT¿S SUTURES RUPTURED ON ONE SIDE AND IT WAS BLEEDING. THE PATIENT NOTICED THIS ISSUE ON THE TUESDAY EVENING PRIOR TO THE REPORT. THE PATIENT DID NOT HAVE A DOCTOR FOR THEIR DEVICE AND WAS GETTING A REFERRAL FROM THEIR PAIN DOCTOR. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN BY A DOCTOR ON (B)(6) AND THEY REMOVED THE DEVICE AND LEADS ON 2014 (B)(6). THE DEVICE HAD BEEN PUT IN AROUND A YEAR PRIOR TO THE REPORT. THE PATIENT HAD A SMALL HOLE IN THEIR SKIN JUST ON OR ABOVE THE DEVICE. IT WAS BIG ENOUGH THAT YOU COULD SEE THE DEVICE THROUGH THE HOLE. THE PATIENT HAD A MODERATE AMOUNT OF YELLOWISH, BLOODY DISCHARGE FROM THE HOLE IN THE SKIN. THE PATIENT HAD NO IDEA WHEN THIS ISSUE STARTED. THE PATIENT NEVER HAD A FEVER OR CHILLS. CULTURES WERE TAKEN BUT THE READING HAD NOT BEEN REAL CLEAR. THEY DID RULE OUT (B)(6). THE PATIENT HAD A PICC LINE AND WAS RECEIVING ANTIBIOTICS. THEY PLANNED TO REPEAT CULTURES AFTER THE PATIENT WAS ON ANTIBIOTICS FOR 8 DAYS. THE PATIENT WAS IN THE HOSPITAL FROM 2014 (B)(6) TO 2014 (B)(6). THE PATIENT WAS TAKING MEDICATION TO CONTROL THEIR BACK PAIN. THE BACK PAIN WAS THE REASON FOR THEIR DEVICE. THERE WERE NO PLANS TO IMPLANT ANOTHER DEVICE DUE TO THE PATIENT¿S AGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439415 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R