BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2823188 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-10013
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 10, 2012
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER HAD MIGRATED AND THE PATIENT'S PUMP WAS SURGICALLY REVISED. THE REPORTER STATED THAT IN (B)(64) 2011, THE CATHETER "DISCONNECTED FROM INTRATHECAL SPACE" AND A REVISION WAS PERFORMED. DURING THAT TIME, THE PUMP WAS REPOSITIONED AS WELL "TO BE MORE VISIBLE" BECAUSE PATIENT GAINED A LOT OF WEIGHT. THE PATIENT HAD SINCE LOST ABOUT 80 LBS. IT WAS LATER REPORTED BY THE HEALTHCARE PROVIDER (HCP) THAT POST MYELOGRAM ON (B)(6) 2010, NOTED NO SURGICAL LESION. A CATHETER DYE STUDY WAS ALSO PERFORMED ON (B)(6) 2010, BUT THE RESULTS WERE NOT LEGIBLE. THE HCP INDICATED THAT THE SURGICAL REVISION TOOK PLACE ON (B)(6) 2011. IT WAS NOT CLEAR IF THE PUMP AND CATHETER WERE BOTH REVISED AT THAT TIME. THE HCP REPORTED THE PATIENT SYMPTOMS RELATED TO THE EVENT TO BE LOW BACK PAIN THAT WRAPPED AROUND THE PATIENT "LIKE A BELT." THE PATIENT DID REQUIRE HOSPITALIZATION DUE TO THE EVENT AND THE PATIENT OUTCOME WAS REPORTED AS NO INJURY. THE MEDICATION IN THE PUMP WAS MORPHINE. IT WAS POSSIBLE, HOWEVER, UNCERTAIN IF BACLOFEN WAS ALSO A PUMP MEDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R