BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3253001 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12453
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 6, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8703W, LOT# L44972, IMPLANTED: (B)(6) 1998, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL CODE - CONCLUSION CODE ¿ IS BEING UPDATED FOR THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PUMP WAS REPLACED ON THE DAY PRIOR TO REPORT.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER REPORTED A MOTOR STALL OCCURRED WITH NO MOTOR STALL RECOVERY RECORDED IN THE LOGS. THE STALL OCCURRED ON (B)(6) 2013 AT 12:27 THE RECOVERY THE SAME DATE AT 14:19. ANOTHER STALL OCCURRED ON (B)(6) 2013 WITH NO RECOVERY TO DATE. THE CALLER DID NOT BELIEVE THE PATIENT HAD AN MRI OR MEDICAL PROCEDURE, OR THAT THEY WERE EXPOSED TO ENVIRONMENTAL EMI. THE PATIENT HEARD THEIR PUMP ALARM ON (B)(6) 2013, AND ON THE DAY OF THE REPORT THE PATIENT HAD INCREASED PAIN AND WAS IN THE HOSPITAL. IT WAS RECOMMENDED THAT THE PUMP BE PROGRAMMED TO MINIMUM RATE AND THE PUMP BE REPLACED. THE MEDICATION USED WITHIN THE SYSTEM WAS MORPHINE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE REPORTER AGAIN STATED THAT 6 MONTHS TO 1 YEAR AGO, THEY BEGAN HAVING A SERIES OF ISSUES WITH THE PUMP WHERE THEY DID NOT BELIEVE IT WAS DELIVERING THE MEDICATION. THE PUMP WAS REPLACED PER THE REPORTER ON (B)(6) 2014 AND THE PATIENT WAS REPORTEDLY DOING OKAY NOW.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED ON (B)(6) 2013 AT APPROXIMATELY 5:00 AM, THE PUMP EMPTIED ITSELF CAUSING THE PATIENT TO BE TAKEN BY AMBULANCE TO A NEARBY HOSPITAL. THEREAFTER, THE PAIN PUMP WAS REMOVED AND THE PUMP WAS SENT TO THE PATHOLOGY DEPARTMENT AT THE (B)(6) HOSPITAL AND THEN THE PUMP WAS SENT BACK FOR ANALYSIS. IT WAS FURTHER REPORTED THE PATIENT HAD ANOTHER PAIN PUMP INSTALLED AND WISHED TO KNOW WHAT OCCURRED WHEN THE PRIOR PAIN PUMP ¿MALFUNCTIONED.¿ A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353775 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R