BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3090371 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-07226
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 10, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. ANALYSIS OF THE CATHETER REVEALED CORING-TEARS-CUTS IN THE PUMP CONNECTOR SEAL DUE TO PUMP OUTLET PORT ¿ NOT USER RELATED. THE CATHETER WAS RECEIVED WITH A BROKEN SUTURE RING ¿ THIS WAS FELT TO BE USER RELATED. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT WAS GETTING THERAPEUTIC EFFECT, BUT THE PHYSICIAN THOUGHT THERE WAS A MICRO FRACTURE IN THE CATHETER OR THE CONNECTION WAS NOT SEATED PROPERLY. IN ADDITION, THE PATIENT HAD LOST A LOT OF WEIGHT. THE PATIENT WAS SCHEDULED FOR A PUMP REPLACEMENT WITH POSSIBLE CATHETER REVISION IN MID-MAY. IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED AND THE CATHETER WAS REVISED. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PATIENT WAS RECEIVING GOOD THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING UPPER BACK PAIN. THE PHYSICIAN AGGRESSIVELY INCREASED THE DOSE, BUT THE PATIENT WASN'T GETTING A 'WHOLE LOT' OF RESPONSE. THERE WERE NO VOLUME DISCREPANCIES NOTED. THE PATIENT HAD UNDERGONE A DYE STUDY AND A MAGNETIC RESONANCE IMAGING (MRI) OF THE THORACIC SPINE BECAUSE THE PHYSICIAN THOUGHT THE PUMP WAS NOT WORKING. THE PHYSICIAN ALSO WANTED TO RULE OUT ANY ADDITIONAL SPINE 'ISSUES.' THE RESULTS OF THE MRI AND DYE STUDY WERE PENDING AT THE TIME OF THIS REPORT. THE PATIENT'S PERSONAL THERAPY MANAGER (PTM) BOLUS 'VOLUME' WAS DECREASED AND THE MORPHINE CONCENTRATION WAS INCREASED TO 0.5 MG- 1MG/ML. THE PUMP WAS DELIVERING MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191739 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention