BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800848 · Received May 8, 2014

    Report

    Report Number
    3007566237-2014-01283
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN. PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE CATHETER, PRODUCT ID 8637-40, SERIAL# (B)(4), PRODUCT TYPE PUMP. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW DETERMINED THE REPORTED DEVICE WAS NOT RELATED TO THE EVENT. ALL ADDITIONAL INFORMATION WILL BE REPORTED UNDER MANUFACTURER REPORT # 3004209178-2014-12519.

    Description of Event or Problem · 1

    IT WAS REPORTED ON THE MORNING OF THIS REPORT A TWO TONED ALARM WAS HEARD, WHICH ¿BEEPS EVERY 5-6 SECONDS.¿ IT WAS NOTED TELEMETRY DID NOT CONFIRM THE ALARM. IT WAS ALSO REPORTED THE DOCTOR WAS CALLED, BUT HE WAS ON VACATION. THE PUMP WAS BEING USED TO DELIVER DILAUDID. IT WAS FURTHER REPORTED THE PATIENT¿S PUMP HAD A CRITICAL ALARM AND NORMAL BATTERY DEPLETION. IT WAS REPORTED THE EMERGENCY ROOM (ER) PHYSICIAN STATED THE PATIENT WAS SCHEDULED FOR A REPLACEMENT ON 2014-(B)(6) AND NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED, BUT WOULD BE IN THE FUTURE. IT WAS FURTHER REPORTED THE PATIENT SHOWED UP IN THE ER WITH A CRITICAL ALARM AND THE PUMP WAS IMPLANTED IN 2005 AND WAS SCHEDULED TO BE REPLACED. IT WAS NOTED THE ER DID NOT HAVE EQUIPMENT TO READ THE PUMP AND THE PATIENT WAS TO BE TRANSFERRED TO A DIFFERENT HOSPITAL FOR QUICKER PATIENT CARE. THE PATIENT WAS HAVING INCREASED PAIN AND STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS ALARMING NOTING IT WAS A ¿FRENCH HORN¿ SOUND AND THAT THE PATIENT WAS ¿DEFINITELY IN WITHDRAWAL¿ SO "THE PUMP STOPPED OR SOMETHING.¿ IT WAS NOTED THE PUMP WAS BEEPING EVERY TWO MINUTES AND THE HEALTHCARE PROVIDER (HCP) COULD NOT READ/INTERROGATE THE PUMP AND THAT HE HAD ¿NEVER HEARD THAT SOUND FROM THE PUMP.¿ IT WAS ALSO REPORTED LAST WEEK THE PATIENT FELL AND BROKE HER WRIST AND ¿FELT LIKE SHE LANDED HARD ON HER PUMP.¿ IT WAS NOTED THE HCP WAS UNABLE TO INTERROGATE THE PUMP AND WAS READING THE PUMP IN THE SAME ROOM WHERE HE DID ALL PUMP REFILLS AND HAD NOT HAD PROBLEMS READING OTHER PUMPS THERE. THERE WERE NO SOURCES OF ELECTROMAGNETIC INTERFERENCE (EMI) PRESENT, IT WAS A SHALLOW IMPLANT, AND THE HCP COULD FEEL WHERE THE PUMP WAS IN THE ABDOMEN. THE HCP WAS TO DISCUSS WITH THE PATIENT THE OPTION TO REPLACE THE PUMP ON 2014-(B)(6) AND THE ELECTIVE REPLACEMENT INDICATOR (ERI) CURRENTLY READ 67 MONTHS. IT WAS REPORTED THE PUMP WAS ALARMING CONTINUOUSLY SO IT WAS REPLACED ON 2014-(B)(6) AND THE PUMP WAS NOT ABLE TO BE INTERROGATED DURING THE CASE. IT WAS NOTED IT WAS NOT ATTEMPTED TO INTERROGATE THE PUMP OUTSIDE OF THE HOSPITAL. THE PUMP WAS NOT DUE FOR A REFILL UNTIL 2014-(B)(6). ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS EXPLANTED AND REPLACED ON 2014-(B)(6). IT WAS ALSO REPORTED THE PATIENT REPORTED TO THE ER BECAUSE THE CRITICAL PUMP ALARM WAS SOUNDING CONSTANTLY AND THE PUMP WAS UNABLE TO BE INTERROGATED, DESPITE MANY TRIES. IT WAS NOTED THE PATIENT RECOVERED WITHOUT SEQUELA AND THERE WAS NO PATIENT INJURY. IT WAS REPORTED THE PUMP WAS DIFFICULT TO INTERROGATE AND THE CAUSE OF THE DIFFICULTY WAS NOT DETERMINED. THE PUMP WAS REPLACED DUE TO NORMAL BATTERY DEPLETION AND THE PATIENT WAS SCHEDULED FOR PROCEDURE AT THE TIME OF THE ALARM, BUT ¿JUST NEEDED TO MOVE THE DATE UP.¿ THE PUMP WAS TO BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS ABLE TO BE INTERROGATED DURING THE CASE. IT WAS PREVIOUSLY REPORTED THAT THE PUMP WAS NOT ABLE TO BE INTERROGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277296 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention