BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3913342 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12519
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 18, 2017
    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
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PREVIOUSLY REPORTED CONCLUSION CODE IS BEING UPDATED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN; PRODUCT ID 863740, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: PUMP; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE PUMP (SN (B)(4)) FOUND THERE WAS AN ISSUE WITH THE HYBRID SOLDER BRIDGING. THE LACK OF TELEMETRY WAS DUE TO A SOLDER BRIDGE BETWEEN ADJACENT SOLDER BUMPS, XD2 AND XD3, ON THE L334 (U1) IC. DUE TO THE HYBRID ANOMALY FOUND, TELEMETRY COULD NOT BE PERFORMED. LOGS COULD NOT BE ACQUIRED AND STANDARD PERFORMANCE TESTS COULD NOT BE PERFORMED. AFTER HYBRID WAS REMOVED, A RESET OCCURRED, AFTER WHICH AND IR COULD NOW BE ACQUIRED, HOWEVER, AN IP WAS STILL NOT POSSIBLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE ALARM WAS NOT CONFIRMED AT THE TIME OF THIS CALL BECAUSE THE PUMP HAD NOT YET BEEN CHECKED BY THE HEALTHCARE PROFESSIONAL (HCP) .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED ¿INJURIES¿ CAUSED BY A ¿DEFECTIVE¿ DEVICE SYSTEM. NO FURTHER INFORMATION WAS PROVIDED INCLUDING WHAT THE SPECIFIC INJURIES CONSISTED OF. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 PHYSICIAN STATED THE PATIENT WAS SCHEDULED FOR A REPLACEMENT ON (B)(6) 2014 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 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 (B)(6) 2014 AND THE ELECTIVE REPLACEMENT INDICATOR (ERI) CURRENTLY READ 67 MONTHS. IT WAS REPORTED THE PUMP WAS ALARMING CONTINUOUSLY SO IT WAS REPLACED ON THE DATE OF THIS REPORT 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 (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS EXPLANTED AND REPLACED ON (B)(6) 2014. 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 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. ADDITIONAL INFORMATION RECEIVED REPORTED THE WRONG SERIAL NUMBER WAS INITIALLY REPORTED. REFER TO MANUFACTURER REPORT # 3007566237-2014-01283 FOR INFORMATION REPORTED UNDER AN INCORRECT SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389464 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention