BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4143066 · Received October 6, 2014

    Report

    Report Number
    3004209178-2014-18314
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 12, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS FRACTURED AFTER THE PATIENT TOOK A FALL. THE DISTAL FRACTURE WAS CONFIRMED VIA X-RAY AND A REVISION WAS DONE (B)(6) 2014 WHERE A NEW CATHETER WAS PLACED. THE PATIENT EXPERIENCED INCREASED TIGHTNESS AND PAIN, BUT THE REPORTER DID NOT KNOW WHEN THE SYMPTOMS BEGAN OR WHEN THE CATHETER FRACTURE WAS DIAGNOSED. THE PATIENT WAS PUT ON ORAL BACLOFEN SO THE PATIENT WOULD NOT GO THROUGH WITHDRAWAL. PER THE REPORTER, THE REVISION WAS SUCCESSFUL AND ¿EVERYTHING¿ WENT WELL. THE PATIENT HAD NO SYMPTOMS AND WAS ¿FINE¿. THE PUMP WAS USED TO DELIVER GABLOFEN.

    Description of Event or Problem · 1

    FURTHER DETAILS OF THE EVENT WERE PROVIDED WHICH REVEALED THAT THE PATIENT FELL IN (B)(6) OF 2014 AND NOT RELATED TO THE DEVICE BUT RATHER THE PATIENT LOST THEIR BALANCE. THE PATIENT'S CATHETER FRACTURED WAS A RESULT OF THE FALL. THE PUMP AND CATHETER WERE REPLACED ON (B)(6) 2014. THE PATIENT'S SYMPTOMS INCLUDED INCREASED TONE AND STIFFNESS, UPPER/LOWER EXTREMITIES HAD DECREASED MOBILITY, DECREASED AMBULATION, AND DECREASED RIGHT UPPER EXTREMITY FUNCTION. IT WAS INITIALLY REPORTED THAT THE ENTIRE CATHETER (8709) WAS EXPLANTED. HOWEVER, THE HEALTH CARE PROVIDER LATER REPORTED THAT CATHETER SEGMENTS (UNKNOWN WHICH CATHETER) WERE REPORTEDLY LEFT IN THE INTRATHECAL SPACE. CLARIFICATION WAS REQUESTED REGARDING THE CATHETER SEGMENTS IN WHICH THE SEGMENTS WERE CONFIRMED BUT THERE WERE NO FURTHER DETAILS AVAILABLE. REPORTEDLY, THE PATIENT WAS TAKING ZANAFLEX AND ORAL BACLOFEN, ALTHOUGH THE ORAL BACLOFEN WAS NOT NOTED IN THE PATIENT'S RECORDS. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623610 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Hospitalization| R