BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2201341 · Received August 3, 2011

    Report

    Report Number
    3004209178-2011-06020
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP REVEALED NO ANOMALY, NORMAL DEVICE FUNCTION. CATHETER ANALYSIS: 7.6 CM SC ASSEMBLY AND PIN CONNECTOR AND 10.5 CM SEGMENT WAS RETURNED. ANALYSIS CONCLUDED HOLE IN CATHETER THAT WAS MOST LIKELY RELATED TO NO STRAIN RELIEF SHROUD BEING USED.

    Description of Event or Problem · 1

    THE PRODUCT WAS RETURNED WITH NO INFO.

    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 59 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N200196008