BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8735359 · Received June 26, 2019

    Report

    Report Number
    3004209178-2019-12392
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    May 31, 2019
    Report Date
    October 2, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDED RECALL. 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

    THE PUMP WAS RETURNED, AND ANALYSIS FOUND CORROSION AND-OR WEAR AND-OR LUBRICATION AND STALL DUE TO SHAFT-BEARING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY AND A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING DILAUDID 6MG FOR A TOTAL DOSE OF 3.10761 MG/DAY AND CLONIDINE 500 MCG FOR A TOTAL DOSE OF 258.96733 MCG/DAY VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. IT WAS REPORTED DEVICE INTERROGATION ON (B)(6) 2019 SHOWED MULTIPLE MOTOR STALLS AND RECOVERIES. THE MULTIPLE MOTOR STALLS AND RECOVERIES WERE DISCOVERED WHEN RUNNING THE LOGS AFTER AN UN-RECOVERED MOTOR STALL. THE MULTIPLE MOTOR STALLS AND RECOVERIES OCCURRED ON THE FOLLOWING DATES: MOTOR STALL OCCURRED ON (B)(6) 2019 AT 10:39PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2019 AT 5:30AM, A MOTOR STALL OCCURRED ON (B)(6) 2019 AT 11:52AM WITH A MOTOR STALL RECOVERY ON (B)(6) 2019 AT 1:31PM, A MOTOR STALL OCCURRED ON (B)(6) 2019 AT 2:35PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2019 AT 10:12AM (NO PRECIPITATING EVENT IDENTIFIED), A MOTOR STALL OCCURRED ON (B)(6) 2019 AT 11:28PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2019 AT 4:39AM (NO PRECIPITATING EVENT IDENTIFIED), A MOTOR STALL OCCURRED ON (B)(6) 2019 AT 7:23AM WITH A MOTOR STALL RECOVERY ON (B)(6) 2019 AT 6:50PM (NO PRECIPITATING EVENT IDENTIFIED), A MOTOR STALL OCCURRED ON (B)(6) 2019 AT 2:18PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2019 AT 1:37AM (NO PRECIPITATING EVENT IDENTIFIED), A MOTOR STALL OCCURRED ON (B)(6) 2019 AT 3:53PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2019 AT 4:42PM (NO PRECIPITATING EVENT IDENTIFIED), AND A MOTOR STALL OCCURRED ON (B)(6) 2019 AT 9:18PM WITHOUT RECOVERY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2019 AND WAS ADMITTED TO THE OBSERVATION UNIT AT 11:27AM. THE PUMP WAS PROGRAMMED TO BASAL RATE AND INTRAVENOUS (IV) OPIOID SUPPORT WAS INITIATED. THE PATIENT WAS POSTED TO THE OPERATING ROOM (OR) SCHEDULE FOR (B)(6) 2019. ON (B)(6) 2019, THE PRESENTING SYMPTOMS INCLUDED CHILLS, NAUSEA, AND CHEST PAIN. IT WAS NOTED THE PATIENT HAD A CORONARY ARTERY BYPASS GRAFTING (CABG) ON (B)(6) 2019, WHICH IS THE DATE THAT THE MOTOR STALLS SUBSIDED UNTIL INTERROGATION AGAIN FOR REFILL ON (B)(6) 2019. ON (B)(6) 2019 THE PUMP WAS REPROGRAMMED AND MEDICATION WAS ADMINISTERED. THE PUMP WAS EXPLANTED/REPLACED ON (B)(6) 2019. THE DEVICE DISPOSITION WAS RETURNED TO MANUFACTURER. THE ESTIMATED REPLACEMENT DATE WAS DECEMBER 2021. THE HCP THOUGHT THAT IF THE PROGRAMMER ALERTED YOU OF EVENTS SINCE THE LAST INTERROGATION, THEY WOULD HAVE AT LEAST CAUGHT THE ISSUE AT THE TIME OF REFILL BEFORE THE WITHDRAWAL EVENT. IT WAS NOT CLEAR IF THE HCP ROUTINELY READ THE LOGS AT EVERY REFILL. THE HCP STATED THE CLINICIAN PROGRAMMER DID NOT FLAG AT LAST REFILL THAT THE PATIENT HAD INTERMITTENT STALLS. THE OUTCOME OF THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. THE EVENT REQUIRED IN-PATIENT OR PROLONGED HOSPITALIZATION. THE DEVICE DIAGNOSIS WAS PUMP MOTOR STALL AND THE CLINICAL DIAGNOSIS WAS PUMP DRUG WITHDRAWAL. THE ETIOLOGY OF THE EVENT INDICATED THE RELATIONSHIP OF THE EVENT TO THE DEVICE OR THERAPY WAS RELATED AND INDICATED THE RELATIONSHIP OF THE EVENT TO THE IMPLANT PROCEDURE WAS NOT RELATED. THE PATIENT'S WEIGHT WAS (B)(6). THE EVENT DATE WAS (B)(6) 2019. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528786 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R