BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3050816 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05880
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 14, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 8709SC, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE CAUSE OF THE EVENT WAS THE CATHETER; CAUSE UNKNOWN. THE IMPLANTING HCP INDICATED THAT THE PATIENT WAS NO LONGER THEIR CURRENT PATIENT AND THE EVENT HAPPENED AFTER THE PATIENT¿S LAST VISIT. THE PUMP DELIVERED MORPHINE AND BUPIVACAINE. IT WAS LATER REPORTED BY THE FOLLOW UP HCP, THE PREVIOUSLY PLACED INTRATHECAL CATHETER WAS FRACTURED. THE CAUSE OF THE EVENT WAS DUE TO BREAK, TEAR, HOLE. THE PATIENT EXPERIENCED INADEQUATE PAIN CONTROL AND WITHDRAWAL SYMPTOMS. AN X-RAY AND IT PUMP MYELOGRAM WERE DONE (B)(6) 2013. THE PUMP AND CATHETER WERE REPLACED. THE PATIENT WAS HOSPITALIZED. THE PATIENT OUTCOME WAS NOTED AS NON-SERIOUS INJURY/ILLNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BROKEN. THE PATIENT WASN'T FEELING WELL BACK IN (B)(6) AND THE PREVIOUS MANAGING HCP TRIED INCREASING THE PUMP EVERY TIME THE PATIENT WOULD GO IN TO NO AVAIL. THE PATIENT HAD SWITCHED MANAGING HCP'S A MONTH AGO AND THE MEDICATION WAS CHANGED TO DILAUDID WITH NO RESULTS. THE MEDICATION WASN'T GETTING TO THE PATIENT SPINE AS A DYE STUDY WAS CONDUCTED AND THE DYE JUST MAD A POOL. PER THE REPORTER NOTHING WAS COMING OUT OF THE CATHETER; A LEAK IN THE BEND WHERE IT GOES FROM THE PUMP UP THE SPINE AND RIGHT IN THAT BEND, THERE WAS A LEAK. PATIENT WAS SCHEDULED FOR SURGERY TO REPLACE CATHETER. THE PUMP WAS USED TO DELIVER DILAUDID (HYDROMORPHONE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153417 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R