BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2872202 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11802
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4), LOT# B0982157K, IMPLANTED: 2010 (B)(6), (B)(4), LOT# 0202734861, IMPLANTED: 2010 (B)(6), (B)(4), LOT# 0202913966, SERI IMPLANTED: 2010 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED THE EMERGENCY ROOM WITH IMPLANT SITE SHOWING REDNESS. PROBLEM OCCURRED POSTOPERATIVELY. BLOOD COUNT WAS NORMAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THERE WAS NO PATIENT INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE TO US.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT, AT THE TIME OF REPORT, THERE WAS NO EVIDENCE OF INFECTION, THOUGH A CULTURE HAD NOT BEEN DONE. ONLY THE PUMP HAD BEEN REPLACED AND THE PUMP POCKET WAS REPOSITIONED. SIX DAYS LATER, IT WAS REPORTED THAT THE PUMP WAS SENT TO A PATHOLOGIST. FOUR DAYS AFTER THAT, IT WAS REPORTED THAT THE PATIENT WAS FEELING "PERFECT" AND THERE WERE NO SYMPTOMS OF INFECTION SEEN DURING A CLINIC VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R