BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3170702 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10402
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 28, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7495LZ51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 74002, LOT # N226327, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 7495LZ51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3998CWS, LOT # N25966, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS STATED THAT, WHEN HE TURNED OVER WHILE SLEEPING, HE GOT SHOCKED. IT WAS STATED THAT IT WAS NOT AN UNPLEASANT SHOCK AND IT CANCELED THE PAIN. IT WAS STATED THAT THE 'SHOCK' INCREASED WHEN HE TURNED OVER. THE PATIENT CONTROLLED THE LEVEL OF THE 'SHOCK' USING PATIENT PROGRAMMER AND THE STIMULATION ITSELF 'SHOCKED' HIM. THE PATIENT, "GENERALLY, TRIED TO KEEP STIMULATION IN A BARELY CONSCIOUS LEVEL." IT WAS STATED HE DID STILL TURN IMPLANT UP DURING THE DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STIMULATION INCREASED WITHOUT "IT TRYING TO". IT WAS NOTED THAT THE PATIENT HAD MORE PAIN WHEN THEY WERE "MOVING ABOUT WITH THEIR LEGS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271026 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1