BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202729 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-06114
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    May 24, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: REVIEWED AND CONFIRMED / UPDATED RFR, HAZARD, AND CONCLUSION CODES. A GOOD FAITH EFFORT FOR FOLLOW-UP WAS CONDUCTED AND INFORMATION PROVIDED SUPPORTS THE REASON FOR NO FORMAL INVESTIGATION BECAUSE THE DOCTOR REPORTED THAT THE ALLEGATIONS OF PUMP MOVEMENT WERE DUE TO THE PATIENT HAVING EXTRA TISSUE SURROUNDING THE PUMP SINCE SHE GAINED WEIGHT. THE DOCTOR ALSO REPORTED THERE WERE NO PROBLEMS WITH REFILLS. THE PUMP REMAINS IMPLANTED. THE EVENT DID NOT ALLEGE A POTENTIAL MANUFACTURING ISSUE; THEREFORE, A DHR REVIEW WAS NOT REQUIRED. THE EVENT WAS REVIEWED FOR PREVIOUS INVESTIGATIONS AND NONE APPLIED. THE EVENT WAS REVIEWED FOR KNOWN INHERENT RISKS LISTED IN PRODUCT LABELING AND NONE WERE NOTED. REVIEWED FOR ESCALATION TO NCET AND ESCALATION WAS NOT REQUIRED. THERE WERE NO REMEDIAL ACTIONS TAKEN AS A RESULT OF THE EVENT. BASED ON THE EVENT INFORMATION, THERE ARE NO ANOMALIES FOUND WITH THE PUMP AND/OR THERAPY. CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 8598A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PUMP POCKET SITE SEEMS LOOSE AND THE PATIENT CAN FEEL IT RUBBING AND MOVING. THE HCP ALSO HAS DIFFICULTY FINDING THE REFILL PORT. THE PATIENT REPORTS HAVING FALLS IN THE PAST AND LAST FALL, HAD A HEART ATTACK. THE PATIENT ALSO REPORTED GAINING WEIGHT. THE PUMP WAS INFUSING MORPHINE, FENTANYL, AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300820 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR