BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1970154 · Received January 14, 2011

    Report

    Report Number
    6000030-2011-00386
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    January 1, 2008
    Report Date
    January 11, 2011
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WEIGHT LOSS, (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PT EXPERIENCED NAUSEA, VOMITING AND WEIGHT LOSS THAT OCCURRED EVERY THIRD WEEK OF THE MONTH. THE SYMPTOMS BEGAN IN (B)(6) 2008, APPROXIMATELY ONE MONTH LATER, THE PT "SPENT 5 DAYS IN THE HOSPITAL IN A DIABETIC COMA." THE PT WAS SCHEDULED FOR PUMP REPLACEMENT SURGERY (REASON FOR REPLACEMENT NOT REPORTED), BUT THE PT HAD AN INFECTION; THEREFORE THE SURGERY WAS NOT DONE. IT WAS LATER REPORTED THERE WAS AN INFECTION AT THE PUMP SITE. THE PT EXPERIENCED WITHDRAWAL (SPECIFIC SYMPTOMS OF WITHDRAWAL NOT REPORTED). THE PUMP AND CATHETER WERE EXPLANTED IN 2008 (SPECIFIC DATE OF EXPLANT NOT REPORTED). FOLLOWING EXPLANT SURGERY, THE PT EXPERIENCED CSF (CEREBROSPINAL FLUID) LEAKAGE. AS OF 1/11/2011, THE SYMPTOMS WERE "CLEARED." THE PT VISITED 3 HOSPITALS IN 2 WEEKS (DATES AND REASON FOR HOSPITAL VISITS NOT REPORTED). ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, 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 MANUFACTURING 8627L10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R CATHETER: MODEL 8709, LOT# J11012R19| EXPLANTED:| IMPLANTED: