BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7897912 · Received September 21, 2018

    Report

    Report Number
    3004209178-2018-21232
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    September 13, 2018
    Report Date
    December 21, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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.

    Additional Manufacturer Narrative · 1

    TEST RESULTS REFER TO LABORATORY TESTING ON 2018 (B)(6) SHOWED A HEMOGLOBIN DECREASE, LOWER KIDNEY FUNCTION, AND HIGHER LACTATE. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A STUDY. IT WAS REPORTED THE PATIENT'S HEIGHT AND WEIGHT WERE NOT MEASURED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A STUDY. IT WAS REPORTED THAT SEPSIS OCCURRED ON (B)(6) 2018. AT URGENCY CARE, THE PATIENT DEVELOPED A 'SHOCK' IMAGE, PROBABLY BASED ON A HYPOVOLEMIC AND SEPTIC COMPONENT. ON (B)(6) 2018, THERE WAS A RESPIRATORY FOCUS WITH FEVER UNTIL 38.2°C, SPUTA AND ¿DECREASED VAG¿ ON THE RIGHT. AN X-RAY SHOWED AN INFILTRATION RIGHT INFRAHILAR. PIPERACILLIN/ TAZOBACTAM + 1X VANCOMYCIN WERE ADMINISTERED FOR THE SEPSIS ON (B)(6) 2018. TAZOCIN-VANCOMYCIN, LEVOPHED, VASOPRESSIN AND INTRAVENOUS FLUID SUPPLETION WERE ADMINISTERED ON-(B)(6) 2018. OXYGEN THERAPY WAS ALSO ADMINISTERED ON (B)(6) 2018. EXAMINATION ON (B)(6) 2018 SHOWED A LIGHTLY BLOATED BELLY WITH PALPABLE BACLOFEN PUMP, LIMITED SUBCUTANEOUS CREPITATIONS, AND NO TENSION (PAIN). THERE WAS NO BLOOD LOSS. DEVICE INTERROGATION/DEVICE DATA ON (B)(6) 2018 SHOWED NORMAL RESULTS. AN ECHOGRAPHY OF THE ABDOMEN ON (B)(6) 2018 SHOWED AN IMPORTANT DECREASE OF THE SUBCUTANEOUS HEMATOMA AROUND THE PUMP. ACTIVE BLEEDING COULD NOT BE EXCLUDED ON THIS ECHO.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A STUDY. IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY REGARDING A PATIENT RECEIVING INTRATHECAL THERAPY. THE DRUG, DOSE, AND CONCENTRATION WERE UNKNOWN. THE INDICATION FOR USE WAS NOT REPORTED. IT WAS REPORTED THE PATIENT DEVELOPED A POST-OPERATIVE HEMATOMA FOLLOWING A PUMP REPLACEMENT ON (B)(6) 2018. THE PATIENT WAS SWEATY, DEVELOPED HYPOTENSION, AND EXPERIENCED SWELLING AROUND THE PUMP WITH ECCHYMOSIS. THE EVENT RESULTED IN IN-PATIENT HOSPITALIZATION, PROLONGATION OF EXISTING HOSPITALIZATION, AN EMERGENCY ROOM VISIT, AND AN URGENT CARE VISIT. AN ECHOGRAPHY OF THE ABDOMEN ON (B)(6) 2018 CONFIRMED A LARGE HEMATOMA AROUND THE PUMP ON THE RIGHT SIDE. THERE WAS NO INTRA-ABDOMINAL FREE FLUID. THE HEMATOMA WAS REMOVED, AND SURGICAL OBSERVATION ON (B)(6) 2018 REVEALED ¿ACTIVE BLEEDING MEDIAN CRANIAL IN THE WOUND¿; COAGULATION OF THE BLEEDING IN THE WOUND OCCURRED. THE EVENT RESULTED IN A LIFE-THREATENING ILLNESS OR INJURY AND RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. CONFLICTING INFORMATION CLASSIFIED THE HEMATOMA REMOVAL AS ¿MEDICAL OR NON-SURGICAL INTERVENTION¿. X-RAYS OF THE THORAX ON (B)(6) 2018 SHOWED NO PLEURAL FLUID, NO COMPACTIONS, AND NO PNEUMOTHORAX. THE EVENT WAS POSSIBLY RELATED TO THE DEVICE/THERAPY AND POSSIBLY RELATED TO THE IMPLANT PROCEDURE. THE EVENT WAS ONGOING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A STUDY. IT WAS REPORTED THE PATIENT WENT INTO HYPOVOLEMIC SHOCK. ON 2018 (B)(6), VANCOMYCIN WAS ADMINISTERED, AND THE PATIENT UNDERWENT A BLOOD TRANSFUSION. LABORATORY TESTING ON 2018 (B)(6) SHOWED A HEMOGLOBIN DECREASE, LOWER KIDNEY FUNCTION, AND HIGHER LACTATE. ECHOGRAPHY OF THE ABDOMINAL WALL ON 2018 (B)(6) SHOWED NORMAL RESULTS. THE PATIENT WAS ALERT. THE EVENT RESOLVED WITHOUT SEQUELAE ON 2018 (B)(6). ¿OTHER ETIOLOGY¿ NOTED THE CAUSE OF THE EVENT WAS UNKNOWN, AND IT WAS LATER CLARIFIED THE EVENT WAS RELATED TO THE IMPLANT PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A STUDY. IT WAS REPORTED THE EVENT WAS "POSSIBLY" RELATED TO THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT WAS RECEIVING BACLOFEN (500 MCG/ML AT 160.2086 MCG/DAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740145 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R