BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4863502 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-12078
    Event Type
    Injury
    Date Received
    June 23, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE DEVICE FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED DURING AN EXAMINATION ON (B)(6) 2015 THE PATIENT WAS EXPERIENCING ABNORMAL PAIN AND TENDERNESS WITH TOUCH. THE PAIN WAS CONSTANT, SHARP, AND ACHING PAIN OVER THE PUMP IMPLANT SITE. THE SEVERITY WAS NOTED AS MILD AND NOT SERIOUS. IT WAS NOTED AS RELATED TO THE PUMP. THE POCKET REVISION THAT WAS ALREADY REPORTED, WAS FURTHER SPECIFIED AS THE PUMP WAS REPOSITIONED TO A NEW LOCATION INFERIOR OR MORE CAUDAL TO THE EXISTING POCKET IN THE RIGHT LOWER QUADRANT OF THE ABDOMEN. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. THE DRUG THAT WAS USED VIA THE DEVICE SYSTEM WAS DILAUDID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP POCKET REVISION AND PUMP EXPLANT AND REPLACEMENT TOOK PLACE ON (B)(6) 2015. THE REASON FOR THE POCKET RE VISION WAS NOT PROVIDED. NO PATIENT SYMPTOMS WERE REPORTED. THE MEDICATION DELIVERED BY THE DEVICE SYSTEM WAS NOT PROVIDED. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405771 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention