BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1812518 · Received August 16, 2010

    Report

    Report Number
    6000030-2010-06132
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 14, 2010
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2010 THAT THERE WAS AN INTERMITTENT AUDIBLE ALARM FROM THE PUMP AND THAT THERE WAS NO MEDICAL OR THERAPY PROBLEM. IT WAS LATER REPORTED THAT THERE WAS TROUBLESHOOTING OF THE PUMP ROTOR, CONTINUING TREATMENT OF CELLULITIS AND THE PUMP WAS REPLACED. DILAUDID WAS IN THE PUMP. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MFG 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8596, LOT# B003838N60| EXPLANTED:| CATHETER: MODEL 8709, LOT# L57852| IMPLANTED: