BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1926414 · Received November 11, 2010

    Report

    Report Number
    3004209178-2010-09356
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A CRITICAL ALARM WAS OCCURRING DUE TO A MOTOR STALL FROM AN MRI. NO PT SYMPTOMS OR OUTCOME WAS REPORTED. THE DRUG CONTAINED IN THE PUMP WAS NOT REPORTED. ADDITIONAL INFO 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
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N162503| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N238279002