BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3051152 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05942
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 21, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID (B)(4), SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2013 AND A NEW 5-6-5 LEAD WAS IMPLANTED WITH 2 INJEX BI-WING ANCHORS. IT WAS STATED THE PATIENT WAS VERY GOOD POST-OPERATIVELY. REPORTEDLY, THE PATIENT HAD PAIN COVERAGE IN THEIR LEFT LEG WHEN THEY INDICATED 80 PERCENT OF THEIR PAIN WAS. IT WAS NOTED THE PATIENT ALSO GOT SOME PAIN COVERAGE IN THEIR RIGHT LEG. IT WAS STATED THE PATIENT WAS SCHEDULED TO FOLLOW-UP WITH THEIR PHYSICIAN ON (B)(6) 2013.

    Description of Event or Problem · 1

    (B)(4) (CONSUMER) - IT WAS REPORTED THE PATIENT'S DEVICE WAS TURNING "ALL THE WAY UP" ON ITS OWN. IT WAS NOT CLEAR WHEN THIS STARTED TO OCCUR. IT WAS NOTED THAT THIS WAS NOT RELATED TO POSITION CHANGES. (B)(6) 2013 - E1A (REP): IT WAS REPORTED THAT THE PATIENT IS MEETING WITH HIS HEALTHCARE PROVIDER AND A MANUFACTURE REPRESENTATIVE IN (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A X-RAY DONE AND THERE WERE NO CHANGES IN THE STATUS OF THE LEAD. IT WAS NOTED THAT NO MALFUNCTION WERE SEEN AND NO CAUSE OF THE ISSUE WAS DETERMINED. IT WAS ALSO REPORTED THAT THE PATIENT WAS SCHEDULED FOR A LEAD REVISION IN HOPE OF RECEIVING BETTER COVERAGE OF HIS PAINFUL AREA IN THE LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154122 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention