BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3023376 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04297
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    May 11, 2018
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DAY PRIOR TO THIS REPORT, THE PATIENT HAD MISSED A REFILL APPOINTMENT DUE TO FLU-LIKE SYMPTOMS. THE DAY OF THIS REPORT THE PATIENT WAS FOUND UNRESPONSIVE AT HER HOME. THE PATIENT ARRIVED AT THE HOSPITAL AWAKE AND ALERT AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENT WAS STABILIZED AND A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS ORDERED. THE PATIENT REPORTED SHE HAD "PASSED OUT" AND "WAS IN A COMA" BUT DID NOT REMEMBER ANYTHING. IN ADDITION, SHE REPORTED "THEY'VE RUN ALL THESE TESTS" AND THE CAUSE WAS NOT DETERMINED. THE PATIENT HAD HEARD THE ALARM BUT HAD IGNORED IT FOR AN UNKNOWN REASON. SHE DID NOT FEEL THIS EPISODE WAS DUE TO WITHDRAWAL AS SHE HAD USED FENTANYL LOLLIPOPS FOR BREAKTHROUGH PAIN. THE LOW RESERVOIR HAD OCCURRED ON (B)(6) 2013 AND THE EMPTY RESERVOIR ALARM OCCURRED ON (B)(6) 2013. THE PATIENT WAS BEING SUPPLEMENTED WITH ORAL MEDICATION AND THE PUMP WAS EXPECTED TO BE REFILLED ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT REMAINED HOSPITALIZED AND PUMP WAS NOT SCHEDULED TO BE EXPLANTED. IT WAS UNKNOWN IF THE PATIENT WAS TRULY IN A COMA OR IF THE COLLAPSING IN HER HOUSE WAS RELATED TO THE PUMP. THIS DEVICE SYSTEM WAS INITIALLY REPORTED TO HAVE DELIVERED BACLOFEN, CLONIDINE AND MORPHINE. HOWEVER, IT WAS LATER REPORTED THAT THE SYSTEM DELIVERED MORPHINE AND CLONIDINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON FEBRUARY 08, 2018. THE PATIENT REPORTED ON (B)(6), 2013, WHEN THEY WERE FOUND NON-RESPONSIVE ON THE FLOOR IN THEIR HOME, THE PATIENT HAD EXPERIENCED RESPIRATORY ARREST. THE PATIENT WAS PUT ON LIFE SUPPORT. THE PATIENT REPORTED THEY WERE IN THE INTENSIVE CARE UNIT (ICU) FOR EIGHT DAYS, AND THE PATIENT WAS DUE TO HAVE THEIR PUMP REFILLED ON (B)(6), 2013. IN (B)(6) OF 2013 THEIR PUMP STARTED BEEPING, AND IT WAS CRITICALLY ALARMING. THE PUMP WAS EMPTY. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THIS EVENT. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126682 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| L| R