BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3193534 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10977
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 5, 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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN ADMITTED THROUGH A NURSING HOME. IT WAS STATED THAT THE PHYSICIAN WAS CONCERNED BECAUSE, THE PATIENT WAS STILL COMPLAINING OF PAIN. IT WAS NOTED THAT, ACCORDING TO THE DIARY, ¿IT¿S DISABLED¿ AND HE WASN¿T ABLE TO ACTIVATE THE PERSONAL THERAPY MANAGER (PTM) TO GIVE HIMSELF A BOLUS. HOWEVER, IT WAS FOUND THAT THE BOLUS PROGRAMMING HAD BEEN DONE, AS THE PTM BOLUS DOSE WAS SET AT 0.05MG. THE REPORTER WAS UNCERTAIN IF THE PATIENT HAD A PRESCRIPTION FOR THE PTM AND PATIENT-ACTIVATED DOSE FUNCTION. IT WAS STATED THAT THE PATIENT WOULD BRING THE PTM TO THE REPORTER ON THE FOLLOWING DAY. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID. THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT HAD BEEN SENT TO THE CLINIC TO MAKE SURE THE PUMP WAS WORKING. THE REPORTER STATED THAT SHE HAD ACCESSED THE PUMP AND IT WAS WORKING. AT THE TIME OF REPORT, TROUBLESHOOTING WAS GOING TO BE ATTEMPTED ON THE PTM. HOWEVER, IT WAS FOUND THAT THE DEVICE WOULDN¿T EVEN TURN ON. THE REPORTER STATED THAT SHE THOUGHT THE ISSUE WAS WITH THE BATTERIES. IT WAS UNKNOWN HOW LONG IT HAD BEEN SINCE THE BATTERIES WERE LAST CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293645 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization