BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3120657 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07920
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    May 1, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3998, LOT # V015626, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE PRIOR WEEK WHEN THE PATIENT WOULD TAKE A DRINK THEY WOULD EXPERIENCE A SHOCKING FEELING AND PAIN UNDER THEIR RIBS. IT WAS FURTHER STATED TO HAVE BEEN ON THE LOWER LEFT SIDE OF THEIR RIBS NOT TOO FAR FROM THE INCISION SITE. IT WAS ALSO STATED THE PATIENT NOTICED A ¿RED PAIN UNDER THE LEFT RIB.¿ IT WAS REPORTED THE PATIENT DID NOT USE THE STIMULATOR AND DID NOT FEEL STIMULATION. IT WAS NOTED THE WEEK PRIOR THE PATIENT WAS ¿WORKING ON SOMETHING¿ IN THE GARAGE ON THEIR BACK AND THEY ¿ABUSE BACK PRETTY GOOD.¿ THE PATIENT WAS ¿WONDERING IF ANYTHING SHORTED OUT.¿ IT WAS NOTED THE PATIENT HAD A PUMP REFILL THE WEEK PRIOR AND ¿EVERYTHING LOOKED GOOD.¿ IT WAS UNCLEAR IF THE IMPLANTABLE NEUROSTIMULATOR WAS LOOKED AT THE TIME. IT WAS LATER CONFIRMED THE IMPLANTABLE NEUROSTIMULATOR WAS OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221479 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1