BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3973706 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13841
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, LOT # HG04HH705, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, LOT # J10928R46, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, LOT# J10928R46, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    A CATHETER ISSUE WAS REPORTED. THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2014 WITH A RUNNING NOSE, NAUSEA, AND C RAMPING. ADDITIONAL PATIENT SYMPTOMS/ COMPLICATIONS ASSOCIATED WITH THE EVENT INCLUDED FLU-LIKE SYMPTOMS. THE PUMP WAS INTERROGATED AND NO MOTOR STALLS APPEARED IN THE LOGS. COMPUTED TOMOGRAPHY (CT) SHOWED A POTENTIAL KINK IN THE CATHETER; X-RAYS WERE ALSO DONE. A REPLACEMENT WAS PERFORMED ON (B)(6) 2014, AND PER THE REPORTER, THE HEALTHCARE PROVIDER (HCP) STATED THAT THEY COULD NOT ASPIRATE THE CATHETER DURING THE REVISION. ADDITIONALLY, THE PATIENT NOTED THAT THE PUMP WAS WORKING AND THERE WERE NO SYMPTOMS PRIOR TO REPLACEMENT. IT WAS NOTED THE ISSUE WAS NOT RESOLVED, NOR WAS THE CAUSE OF THE ISSUE DETERMINED. THE PATIENT REQUIRED HOSPITALIZATION AND WAS HELD FOR OBSERVATION, AND WAS SUPPLEMENTED WITH ORAL MORPHINE AND CLONIDINE. THE PUMP WAS BEING USED TO INFUSE MORPHINE AND CLONIDINE. AS OF (B)(6) 2014, THE CATHETER REMAINED IMPLANTED AND IN SERVICE, AND THE PATIENT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THE PATIENT RECEIVED A NORMAL PUMP REPLACEMENT AND THEN TWO DAYS LATER THEY PRESENTED TO THE ER WITH SYMPTOMS. THE PREVIOUSLY REPORTED DATE, (B)(6) 2014, OF WHEN THE PATIENT PRESENTED WITH THE SYMPTOMS WAS CORRECTED TO (B)(6) 2014. AN X-RAY WAS DONE AS PREVIOUSLY REPORTED AND THEY COULDN¿T SEE ANYTHING DEFINITIVE BUT WERE UNABLE TO ASPIRATE THE CATHETER. THE HCP AT THAT TIME THOUGHT THERE WAS A POSSIBLE KINK. SUBSEQUENTLY, THE PATIENT HAD THE SURGERY TO REPLACE THE CATHETER AND HAD BEEN RECEIVING EFFECTIVE THERAPY SINCE THAT TIME. THE CATHETER WAS DISPOSED OF IN THE OR SO IT WOULD NOT BE RETURNED. THE LOCATION OF THE ISSUE WASN¿T INVESTIGATED, THE HCP HAD DECIDED TO REPLACE THE CATHETER WHEN THEY WERE UNABLE TO ASPIRATE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449879 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R