BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1926261 · Received November 11, 2010

    Report

    Report Number
    3004209178-2010-09260
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MEDTRONIC 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

    THE PUMP WAS FILLED IN SEPTEMBER. NO CHANGES WERE MADE TO THE MEDICATIONS IN THE PUMP OR THE PROGRAMMING OF THE PUMP. THE LAST WEEK OF SEPTEMBER, THE PT WAS SUDDENLY EXTREMELY DIZZY, CONSTIPATED, TIRED, AND HAVING PROBLEMS THINKING/CONCENTRATING; THE PT WOULD FALL ASLEEP WHILE SITTING AT THE COMPUTER. THE PUMP WAS "HOT TO THE TOUCH THE OTHER DAY." IT WAS NOTED THAT THE DOG HAD JUMPED ON THE PT AND THE PT FELL FORWARD ON THE PUMP ON THE EDGE OF THE BED. THE PT WAS DUE FOR A REFILL IN MID-NOVEMBER. FOLLOW-UP WITH THE PT'S PHYSICIAN WAS RECOMMENDED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 42 YR CATHETER: MODEL 8709SC, LOT #: N231136014| IMPLANTED:| EXPLANTED: