BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1943908 · Received December 28, 2010

    Report

    Report Number
    3004209178-2010-10804
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    October 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS HAVING DIFFICULTY USING THE PERSONAL THERAPY MANAGER (PTM). THE PT WAS GETTING A POOR COMMUNICATION SCREEN SINCE CHANGING THE BATTERIES. THE PTM WAS POSITIONED OVER THE PUMP BY MEANS OF "GRABBING" THE PUMP UNDER THE SKIN AND HOLDING THE PTM OVER THE PUMP. THE PUMP OUTLINE WAS EASILY SEEN UNDER THE SKIN. THE LAST REFILL WAS SUCCESSFUL, BUT THE DOCTOR HAD CONCERNS ABOUT THE PUMP BEING FLIPPED. THE DOCTOR "FELT" THE PUMP STATING THERE WAS NO FLIP. THE PTM WAS REPLACED AND THE PT WAS STILL UNSUCCESSFUL IN DELIVERING A BOLUS DOSE; STILL GETTING A POOR COMMUNICATION SCREEN. DIFFERENT ROOMS WERE TRIED, THE PT EVEN WENT OUTSIDE. THE PT PLANNED TO RECONTACT HER PHYSICIAN. IT WAS LATER REPORTED THAT THE PT DID VISIT HER PHYSICIAN. THE PUMP MEDICATIONS WERE ADJUSTED. THE PT HAD SURGERY ON (B)(6) 2010 (THE DETAILS WERE NOT PROVIDED). THE PT WAS NO LONGER HAVING PROBLEMS WITH HER SYSTEM. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention PROGRAMMER: MODEL 8835, LOT #: NPG012889N| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT #: N200087001| PROGRAMMER: MODEL 8835, (B)(4)