BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2963381 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02694
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 24, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS DUE TO NORMAL BATTERY DEPLETION. THERE WERE NO ABNORMAL IMPEDANCES. IT WAS STATED THAT THE PATIENT WAS UNSURE IF HE WANTED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL AND DISLOCATED THEIR SHOULDER ABOUT A WEEK PREVIOUS TO THE DATE OF THIS REPORT. IN ADDITION, IT WAS NOTED THE PATIENT HAD A 'COUPLE OF FALLS.' SINCE THEN, IT WAS STATED THE PATIENT WAS NOT GETTING GOOD PARESTHESIA IN THE CORRECT PLACE. REPROGRAMMING WAS ATTEMPTED TO ACHIEVE OPTIMAL PARESTHESIA, BUT IT WAS UNSUCCESSFUL. IMPEDANCES MEASURED SHOWED THAT ALL ELECTRODES EXCEPT ONE WERE IN RANGE. THE OUT OF RANGE ELECTRODE WAS ON THE LEAD THAT CONTAINS ELECTRODES 8-15. THAT ELECTRODE WAS NOT BEING USED WITH THE PATIENT'S PROGRAMMING. IT WAS NOTED THE PATIENT WAS GETTING 'UNCOMFORTABLE PAIN' WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED ON AND WAS NOT GETTING ANY RELIEF. AN ESTIMATED REPLACEMENT INDICATOR WAS REPORTED AS WELL. IT WAS FURTHER NOTED THE INS BATTERY WAS 'ALMOST DEAD.' IT WAS STATED THE PATIENT WAS TO TURN OFF THE INS WHILE THEY HEAL FROM THE SHOULDER SURGERY THAT WAS DUE TO THE FALL. THE DEVICE WOULD BE RE-INTERROGATED/REPROGRAMMED IN ABOUT FOUR WEEKS. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68935 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1