BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3242831 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12169
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 4, 2013
    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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPON RETURN TO THE ANALYSIS LABORATORY TELEMETRY WAS NOT POSSIBLE. ANALYSIS REVEALED THAT THE HYBRID AND INNER COVER WAS SPLATTERED WITH A FOREIGN MATERIAL THAT THROUGH ANALYSIS WAS DETERMINED TO BE GLYCERIN. THIS MATERIAL WAS COMPARED AGAINST BATTERY ELECTROLYTE AND THE PRESSURE SENSITIVE ADHESIVE WITH NO MATCH. AS OF NOW WITH THE ANALYSIS THAT HAD BEEN PERFORMED, IT DID NOT APPEAR THIS GLYCERIN WAS DIRECTLY ASSOCIATED WITH ANY NATIVE COMPONENTS OF THE PUMP. THE GLYCERIN APPEARED TO HAVE DAMAGED THE HYBRID AND PROMOTED CORROSION AND SHORTING. AFTER HYBRID REMOVAL, A POWER ON RESET (POR) OCCURRED ALLOWING INTERROGATION TO BE PERFORMED SHOWING THE PUMP WAS IN AN UNDEFINED STATE. THE HYBRID WAS SENT FOR FURTHER EXAMINATION IN AN EFFORT TO DETERMINE WHAT COMPONENTS ARE AFFECTED AND DAMAGED BY THE FOREIGN GLYCERIN. THIS ANALYSIS WAS PENDING. IN CONCLUSION, THE PUMP HAS FOREIGN MATERIAL INSIDE THE PUMP WHICH WAS DETERMINED TO BE GLYCERIN. HOWEVER, TO DATE, THE SOURCE OF THE GLYCERIN WAS UNDETERMINED. BATTERY RESISTANCE TESTING WAS PERFORMED AND FOUND TO PASS WITH 35 OHMS. A SUPPLEMENTAL REPORT WILL BE SHOULD ADDITIONAL INFORMATION BE RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS DOING WELL AND NO EXPLANT WAS SCHEDULED. THERE WAS TO BE PATIENT FOLLOW-UP AT EVERY REFILL APPOINTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A CRITICAL ALARM WAS HEARD. A BATTERY RESET MESSAGE AND A SAFE STATE OCCURRED. IT WAS SAID THE PATIENT HAS AN APPOINTMENT ON THE TUESDAY AFTER THIS REPORT DATE AND THE HEALTH CARE PROVIDER (HCP) WOULD'VE DETERMINED AT THAT TIME IF EXPLANT WAS NECESSARY. TROUBLESHOOTING WAS ATTEMPTED AND INCLUDED INTERROGATION FILL AND REFILL. THE PATIENT HAD AN INCREASE IN SPASTICITY, UNDERDOSE SYMPTOMS, AND A RASH AT THE DEVICE POCKET. THE PUMP WAS USED TO DELIVER BACLOFEN.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT A MOTOR STALL OCCURRED WHICH NEVER RECOVERED. IT WAS AGAIN NOTED THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS. THE PUMP SYSTEM WAS BEING USED TO DELIVER LIORESAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PUMP WAS ACTUALLY IMPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343748 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Required Intervention