BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2251166 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07562
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Report Date
    September 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P840004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL RECORDED IN EVENT LOGS WITH MOTOR STALL RECOVERY WAS REPORTED. PER THE REPORTER THERE WERE MULTIPLE MOTOR STALLS AND THAT "IT DIDN'T FEEL THE PT COULD HAVE BEEN IN A STRONG MAGNETIC FIELD DURING ALL OF THEM." PT EXPERIENCED AN UNDERDOSE. IT WAS ALSO STATED THAT THE ALARM COULD NOT BE HEARD BY THE PT WHEN IT WAS TESTED SOME TIME AGO AND A PUMP REPLACEMENT WAS CONSIDERED BUT IT WAS NOT DECIDED TO DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER: MODEL 8598, LOT# N062431025| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N219346029