BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2220251 · Received August 16, 2011

    Report

    Report Number
    3004209178-2011-06454
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    January 1, 2010
    Report Date
    August 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT "A SINGLE MEDIUM TONE BEEP" WAS OCCURRING EVERY 3 MINUTES DUE TO LOW RESERVOIR ALARM AND THE PUMP HAD SINCE BEEN FILLED AND UPDATED. IT WAS LATER REPORTED THAT THERE WAS "DEHISCENCE" AND A REVISION WAS DONE. THE DRUGS DELIVERED INCLUDED MORPHINE SULPHATE 60 MG/ML AT THE RATE OF 5.994 MG/DAY. DOSE ADJUSTMENT WAS DONE ON (B)(6) 2010 AND THERE WAS IMPROVED PAIN RELIEF. THERE WERE NO REPORTED PT SIGNS AND SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N143748006| IMPLANTED: