BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3242744 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12164
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, LOT# N126907, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, LOT# J0039991R, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL REVISION IN 2010 TO HAVE THE PUMP MOVED FROM HER BACK TO HER FRONT. THE PATIENT STATED THAT WHEN THE PUMP WAS INITIALLY IMPLANTED IT WAS ¿IN A TERRIBLE PLACE¿. THE PATIENT ALSO STATED THAT WHEN SHE WOULD SIT IN A CHAIR AND GET UP THE PUMP WOULD CATCH ON THE CHAIR. THE PATIENT TOLD THE HEALTHCARE PROVIDER (HCP) TO EITHER MOVE THE PUMP OR EXPLANT THE PUMP. THE DEVICE SYSTEM DELIVERED HYDROMORPHONE AND BUPIVACAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE WAS ATTRIBUTED TO THE PUMP PLACEMENT. THE PATIENT ALSO EXPERIENCED PAIN AT THE PUMP SITE DUE TO THE POSITION OF THE PUMP. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342499 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention