BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1872562 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07841
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT SHE WAS GETTING "ELECTRICAL SHOCK" BEGINNING AT THE PUMP, TRAVELING UP HER SPINE AND WRAPPING AROUND TO HER STOMACH. PT ALSO HAS A DEFIBRILLATOR FROM A COMPETITOR. PT STATED SHE CAN ALSO CAUSE THE "SHOCK" BY TOUCHING HER SPINE AREA NEAR CATHETER. PT STATED THE SHOCK STILL ORIGINATED FROM THE PUMP AND TRAVELED UP THE CATHETER EVEN WHEN SHE TOUCHED THE AREA OF THE CATHETER. THIS OCCURRED FOLLOWING A PUMP AND CATHETER REPLACEMENT. THE PT WAS AT HOME IN FAIR CONDITION. PT STATED SHE HAD A CT SCAN AND SHE WAS INFORMED THE SCAN SHOWED NO ISSUES WERE OCCURING. PT REPORTED THE INCIDENCE WITH WHICH SHE WAS EXPERIENCING THE SYMPTOMS WAS REDUCED TO JUST A COUPLE TIMES A MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT#: J53426R03