BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3061884 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06377
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    April 17, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PATIENT PROGRAMMER MODEL 8835, SERIAL# (B)(4); CATHETER MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012; PHYSICIAN PROGRAMMER MODEL 8840, SERIAL# UNKNOWN; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD FLIPPED. THE HEALTHCARE PROVIDER (HCP) FLIPPED IT BACK INTO PROPER POSITION AND CONFIRMED IT WAS PROPERLY POSITIONED VIA FLOURO AND THE CATHETER 'LOOKED FINE.' PRIOR TO REPOSITIONING THE PUMP THE HCP HAD TROUBLE READING THE PUMP, ONCE THE PUMP WAS FLIPPED BACK INTO PROPER POSITION THEY WERE ABLE TO INTERROGATE WITHOUT DIFFICULTY. IT WAS NOTED THAT THE PATIENT WAS 'STILL GETTING THERAPY OK.' THE DEVICE SYSTEM AS USED TO INFUSE HYDROMORPHONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT FLUOROSCOPY WAS USED TO CORRECT THE FLIPPED PUMP ON (B)(6) 2013. THERE WAS NO HOSPITALIZATION AND NO PATIENT INJURY AS AN OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162820 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention