BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1665667 · Received April 20, 2010

    Report

    Report Number
    3004209178-2010-03226
    Event Type
    Death
    Date Received
    April 20, 2010
    Report Date
    March 25, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED (DATE NOT SPECIFIED); THE SYSTEM WAS RETURNED TO THE MFR. IT WAS NOTED THAT AN X-RAY FROM APPROXIMATELY (B) (6) 2010 REVEALED THE CATHETER 1 CM BEYOND FORAMEN MAGNUM. IT WAS 'UNKNOWN' IF THE EVENT WAS ATTRIBUTED TO THE DEVICE SYSTEM; THE CAUSE OF DEATH WAS NOTED AS 'PRESUMED UNDERLYING HALLOVORDEN-SPATZ - PKN'. ADDITIONALLY, THE HCP NOTED THAT THERE WAS 'RAPID PROGRESSION OF UNDERLYING DISEASE LED TO PUMP PLACEMENT'.

    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 Death PROGRAMMER: MODEL 8840, LOT# UNK| CATHETER: MODEL 8709SC, LOT# N230352007| IMPLANTED:| EXPLANTED: