BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3040544 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04845
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 25, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID:37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, 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 RECEIVED FROM THE HCP REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE PAIN FOLLOWING THE INITIAL PLACEMENT OF THE DEVICE. NO INTERVENTIONS WERE TAKEN. THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013 AND TWO NEW SETTINGS WERE CREATED TO USE. THE PAIN WAS IMMEDIATELY SIGNIFICANTLY REDUCED AND THE PATIENT REPORTED GREATER THAN 50% IMPROVEMENT COMPAREDTO BASELINE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION, THERE WAS NO INJURY, AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT AFTER THE PATIENT'S IMPLANT WAS PUT IN SHE HAD A REACTION AND HER NERVE ENDINGS WERE INFLAMED. IT WAS REPORTED THAT THE PATIENT "COULDN'T SIT UP OR BREATHE" AND SHE WAS IN AGONY. IT WAS NOTED THAT THE PATIENT WAS DISAPPOINTED AS THE TRIAL HAD BEEN WONDERFUL. IT WAS REPORTED THAT ON (B)(6) 2013 THE PATIENT WAS "CLIMBING WALLS" AND WAS GIVEN NEURONTIN, BUT IT HAD NOT HELPED. THE PATIENT HAD AN APPOINTMENT WITH HER HCP SCHEDULED FOR (B)(6) 2013, BUT STATED THAT "NO ONE IS DOING SQUAT" AND THAT SHE WAS TOLD HER SYMPTOMS WERE NORMAL. IT WAS NOTED THAT THE PATIENT'S DEVICE WAS NOT TURNED ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT¿S DEVICE WAS ¿NOT WORKING ON MY BACK AND DOWN MY LEG LIKE IT¿S SUPPOSED TO.¿ THE PATIENT STATED THAT IT WAS STIMULATING ON HER THIGH INSTEAD OF IN HER BACK AND DOWN THE LEG. IT WAS REPORTED THAT THE PATIENT WAS ¿DISAPPOINTED BECAUSE THE TRIAL WAS SO WONDERFUL.¿ ADDITIONAL INFORMATION REPORTED THAT THE ISSUE WAS DUE TO THE INITIAL PLACEMENT OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143348 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