BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3200976 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11161
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3587A, LOT# L79814, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-09, LOT# LB6696, IMPLANTED: (B)(6) 2003, PRODUCT TYPE ACCESSORY; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 74002, LOT# N334850, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT VOMITED BLOOD MID-APRIL AND WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT LOST A LOT OF BLOOD AND ¿FLAT LINED¿ AND THE DOCTOR USED DEFIBRILLATION AND THEIR CHEST HURT "REAL BAD" FOR THE PAST 6 WEEKS. IT WAS ALSO NOTED THAT THE ISSUES WERE RELATED TO AN ULCER THAT WAS DETECTED. SINCE THE INCIDENT, THE PATIENT WASN¿T ABLE TO CONNECT WITH THE IMPLANT USING THEIR PATIENT PROGRAMMER. IT WAS REPORTED THAT THE PATIENT COULD NOT MAKE ADJUSTMENTS WITH OR WITHOUT THE ANTENNA. THE SCREEN WAS "WEAK AND WORKED ONCE IN A WHILE.¿ THE PATIENT ALSO NOTED COMMUNICATION ERRORS. IT WAS REPORTED THAT SINCE PATIENT WASN¿T SENT A PATIENT PROGRAMMER IT WAS UNKNOWN IF THE SYSTEM WAS WORKING WELL. IT WAS LATER REPORTED THE PATIENT HAD TROUBLE TURNING THERAPY ON AND ONCE ON THEY HAVE TROUBLE TURNING THERAPY OFF. IT WAS NOTED THE THERAPY WAS ¿99%¿ FINE WHEN THE THERAPY WAS ON. THE PATIENT DECLINED A TRANSFER TO REPAIRS FOR REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT¿S CONCERNS WITH THE DEVICE OR THERAPY WERE RESOLVED. IT WAS NOTED THAT THE PATIENT RECEIVED ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR MANUFACTURER¿S REPRESENTATIVE ON (B)(4) 2013. IT WAS REPORTED THAT THE PROBLEM WAS ¿SOL VED¿. IT WAS FURTHER REPORTED THAT THE PATIENT¿S IMPEDANCES WERE WITHIN NORMAL RANGES. IT WAS NOTED THAT THE ¿PATIENT PROGRAMMER WAS BROKEN¿ AND A NEW PATIENT PROGRAMMER WAS SENT TO THE PATIENT OVERNIGHT BY MANUFACTURER. IT WAS REPORTED THAT DEVICE WAS WORKING WELL AND PATIENT¿S ¿COVERAGE WAS ADEQUATE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303532 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR