BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3183696 · Received June 22, 2013

    Report

    Report Number
    3004209178-2013-10742
    Event Type
    Injury
    Date Received
    June 22, 2013
    Date of Event
    May 22, 2013
    Report Date
    November 2, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, LOT# N181554003, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND MOTOR GEAR TRAIN ANOMALIES. CORROSION AND/OR WEAR AND/OR LUBRICATION WERE FOUND AS WELL AS STALL DUE TO SHAFT-BEARING. SIGNIFICANT RESIDUE AND SHAFT WEAR ON THE UPPER SHAFT OF GEAR 2 WAS SEEN. RESIDUE WAS ALSO FOUND ON THE JEWEL WHERE THE UPPER SHAFT OF GEAR 2 INSERTED INTO THE TOP BRIDGE ASSEMBLY.

    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 THE DEVICE STARTED BEEPING THE DAY BEFORE THE INITIAL REPORT WAS MADE. THE LOGS WERE READ, A MOTOR STALL OCCURRED (B)(6) 2013 AT 14:35, MOTOR STALL RECOVERY OCCURRED (B)(6) 2013 AT 21:26. ANOTHER MOTOR STALL OCCURRED (B)(6) 2013 AT 02: 18 AND AS OF 11AM, 9 HOURS AFTER THE STALL OCCURRED NO RECOVERY HAD BEEN NOTED. IT WAS NOTED THAT THE PATIENT DID NOT HAVE MAGNETIC RESONANCE IMAGING. THE PATIENT FELT LIKE HE WAS ¿GOING THROUGH SOME WITHDRAWALS,¿ AND WAS ¿NOT DOING REAL WELL.¿ IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) WAS GOING TO ¿MAKE MOVES¿ TO HAVE THE DEVICE REPLACED. THE DEVICE SYSTEM WAS USED TO INFUSE DILAUDID, MARCAINE, CLONIDINE AND BACLOFEN. IT WAS LATER REPORTED THAT AN EXPLANT WAS PLANNED FOR (B)(6) 2013 AND THE DEVICE WAS TO BE RETURNED TO THE MANUFACTURER. ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED HOSPITALIZATION AND SURGICAL INTERVENTION. SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED PAIN AND SWEATING. IT WAS LATER REPORTED THAT NO ROTOR OR DYE STUDY WAS DONE, PATIENT OUTCOME NOTED AS RECOVERED WITH SEQUELA, SPECIFICS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. PER PUMP LOGS, A MOTOR STALL HAD OCCURRED ON (B)(6) 2013 AT 04:30 AND RECOVERED ON (B)(6) 2013 AT 11:19. ALSO, A MOTOR STALL OCCURRED ON (B)(6) 2013 AT 15:24 FOLLOWED BY RECOVERY ON (B)(6) 2013 AT 22:15. ANOTHER MOTOR STALL OCCURRED AT (B)(6) 2013 AND NO RECOVERY WAS NOTED IN THE PUMP EVENT LOGS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER ON 2017-OCT-31. IT WAS REPORTED THAT THE PUMP STOPPED WORKING/DIED IN 2013. IT WAS NOTED THAT THE EVENT WAS PAINFUL WITH THE WITHDRAWALS THAT OCCURRED. IT WAS FURTHER SPECIFIED THAT THE PUMP WAS INFUSING DILAUDID (28.5MG/ML AT 13.001MG/DAY), BUPIVACAINE (9.5MG/ML AT 4.3335MG/DAY), CLONIDINE (952.0MCG/ML AT 434.27MCG/DAY), AND BACLOFEN (158.0MCG/ML AT 72.07 MCG/DAY). NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284376 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R