BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1193419 · Received October 7, 2008

    Report

    Report Number
    6000030-2008-06386
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN MID-AUGUST, THE PATIENT REPORTED THAT HE MISSED HIS REFILL VISIT AND HE WAS EXPERIENCING UNSPECIFIED WITHDRAWAL SYMPTOMS. THE PATIENT WAS AT HOME. HIS STATUS WAS REPORTED TO BE "FAIR". THE PATIENT WAS ENCOURAGED TO CONTACT HIS HEALTH CARE PROFESSIONAL (HCP). APPROXIMATELY 3.5 WEEKS LATER, THE HCP REPORTED THAT THE PATIENT STATED THAT HE WAS STRUCK BY LIGHTENING. THE PATIENT FELT LIKE THE PUMP WAS NOT WORKING; HE WAS HAVING WITHDRAWAL SYMPTOMS. HIS SYMPTOMS INCLUDED A HEADACHE, NAUSEA, VOMITING, AND INCREASED PAIN. AT ABOUT THREE WEEKS LATER, AN INDIUM DYE STUDY WAS DONE AND THE PUMP WAS FOUND TO BE NON-FUNCTIONING. THE PATIENT WAS SCHEDULED FOR A PUMP REPLACEMENT. THE HCP REPORTED THE PATIENT OUTCOME AS "NO INJURY". THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709| PROGRAMMER: MODEL PROGRAMMER