BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4060391 · Received September 4, 2014

    Report

    Report Number
    3004209178-2014-16373
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DIAGNOSIS UPON DISCHARGE WAS UNKNOWN. THE PATIENT¿S SYMPTOMS BEGAN ON (B)(6) 2014 AND THEY HAD ALSO TRIED SUPPLEMENTING WITH ORAL BACLOFEN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WENT DRY IN (B)(6) 2014, AND THE PATIENT WAS TAKING ORAL MEDICATIONS. THE PUMP WAS REFILLED AND THE PUMP WAS CHECKED AND WAS REPORTEDLY STILL OK. AT THE TIME OF THE REPORT, THE PATIENT WANTED TO GET THE PUMP FILLED AND WAS LOOKING FOR AN HCP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PUMP WAS ALARMING, BUT THE PATIENT WAS NOT GOING THROUGH WITHDRAWAL DUE TO THE HOSPITAL PROVIDING THE PATIENT WITH ORAL BACLOFEN. THE ALARM WAS LATER CLARIFIED AS A LOW RESERVOIR ALARM. THE PATIENT HAD BEEN HOSPITALIZED FOR 62 DAYS AND WAS IN A NURSING HOME FOR 21 DAYS FOR SOMETHING NOT RELATED TO THE PUMP THERAPY. THE NEXT PUMP REFILL WAS SCHEDULED FOR (B)(6) 2014. IT WAS ATTEMPTED TO GET THE PATIENT TO A HEALTH CARE PROVIDER (HCP) THAT WAS MANAGING THE PUMP TO GET THE REFILL ON HER APPOINTMENT DATE, BUT THE PATIENT WAS NOT TRANSPORTED. THE HCP TOOK THE PATIENT ON A LEAVE OF ABSENCE AND THE PATIENT WAS IN THE NURSING HOME TO GET THE REFILL, BUT THE HCP WOULD NOT TAKE HER. THE PATIENT WAS DISCHARGED FROM THE NURSING HOME AND THE HCP ENDED UP ¿CALLING IN SICK 2 TIMES AND WENT TO A FUNERAL.¿ THE PUMP INITIALLY STARTED TO ALARM ON (B)(6) 2014. THE ALARM SOUND CHANGED OVER TO THE POLICE SIREN SOUNDING ALARM 1 WEEK AGO. THE PATIENT HAD ¿10 MLG TIB¿ SUPPLEMENTED TO HER. THE SYSTEM WAS BEING USED TO DELIVER BACLOFEN, BUT THE TYPE OF BACLOFEN WAS NOT KNOWN. IT WAS LATER REPORTED THE PUMP WAS ABLE TO BE REFILLED. IT WAS NOTED THE PATIENT¿S ¿ITCHY, BITCHY, TWITCHY¿ WAS RESOLVED AND EVERYTHING WAS GOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542687 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR