BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4130368 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-18018
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 11, 2014
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE: LEAD; PRODUCT ID 37743FA, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD WIRES OUT OF PLACE IN THE PAST. THE WIRES WERE ¿EVERYWHERE IN HIS BACK.¿ THE PATIENT WAS REACHING BACK TO ITCH OR SOMETHING AND FELT A BUMP. THE PATIENT¿S PHYSICIAN HAD TO GO IN AND FIX IT ON AN UNKNOWN DATE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PATIENTS PHYSICIAN REGARDING THIS EVENT, IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609335 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention