BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2041381 · Received March 24, 2011

    Report

    Report Number
    3004209178-2011-02271
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    December 10, 2010
    Report Date
    March 15, 2011
    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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND; NORMAL DEVICE FUNCTION. ANALYSIS OF CATHETER ((B)(4)) REVEALED ACCEPTABLE CATHETER TESTING; NO ANOMALY SEEN. ANALYSIS OF CATHETER ((B)(4)) REVEALED A CATHETER SLICE CUT; THERE IS A SLICE CUT LOCATED UNDER THE ANCHOR, 27.5 CM FROM THE DISTAL TIP. IT WAS NOTED THAT THE HOLE IN THE CATHETER WAS USER RELATED.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT THE PT WAS NOT GETTING BENEFIT FROM THE DEVICE SYSTEM AND WANTED IT REMOVED. THE DEVICE SYSTEM WAS REMOVED. THERE WAS REPORTED TO BE NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA. THE DEVICES UNDERWENT ROUTINE ANALYSIS UPON RECEIPT; THE PUMP CONTAINED NORMAL SALINE AS REC'D.

    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 40 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8596SC, LOT# N171793034| CATHETER: MODEL 8709SC, LOT# N187472003