BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4874650 · Received June 29, 2015

    Report

    Report Number
    3004209178-2015-12395
    Event Type
    Malfunction
    Date Received
    June 29, 2015
    Report Date
    June 8, 2015
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED:(B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3889-28, LOT# VA0BM8J, IMPLANTED:(B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# VA0BM8J, IMPLANTED:(B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S DEVICE WASN¿T WORKING. SHE WASN¿T GETTING THE PAIN RELIEF SHE HAD BEEN GETTING AND INCREASED ORAL MEDICATION SINCE (B)(6) 2015. THE PATIENT DENIED FALLS, ACCIDENTS, TRAUMAS, AND ANY CHANGES TO PHYSICAL ACTIVITY. SHE INCREASED STIMULATION TO 2.5 VOLTS AND IT WAS COMFORTABLE. SHE HAD AN APPOINTMENT TO SEE A PHYSICIAN THE FOLLOWING WEEK TO ADDRESS THE ISSUE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418476 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1