BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6606132 · Received June 1, 2017

    Report

    Report Number
    3004209178-2017-11482
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    March 22, 2017
    Report Date
    June 1, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID 8598 LOT# B004295N14 IMPLANTED: (B)(6) 2003 EXPLANTED: (B)(6) 2017 PRODUCT TYPE CATHETER PRODUCT ID 8596 LOT# B005121N55 IMPLANTED: (B)(6) 2003 EXPLANTED: (B)(6) 2017 PRODUCT TYPE CATHETER. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A MEDWATCH (UF/IMPORTER REPORT # 06-0010-2017-004) WAS RECEIVED REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN (UNKNOWN TYPE, DOSE AND CONCENTRATION) VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. THE MEDWATCH WAS INDICATED AS HAVING BEEN SUBMITTED TO THE FDA BY A HEALTHCARE PROFESSIONAL (HCP)/RISK MANAGER. IT WAS INDICATED THAT THE PATIENT'S BACLOFEN PUMP WAS IMPLANTED IN (B)(6) 2015 AND WAS NOT DELIVERING ADEQUATE PAIN RELIEF TO THE PATIENT. ON (B)(6) 2017 THE PATIENT HAD AN ADDITIONAL VISIT TO THE EMERGENCY DEPARTMENT DUE TO INADEQUATE PAIN CONTROL. THE HCP WAS UNABLE TO ASSESS WHETHER THE PUMP COMPONENT OR THE CATHETER WAS MALFUNCTIONING. DURING A REVISION SURGERY, A PIECE OF THE CATHETER BROKE OFF AND THE BROKEN PIECE REMAINED IN THE PATIENT AS CONSULT WITH NEUROSURGERY INDICATED THERE WAS MORE RISK TO THE PATIENT TO ATTEMPT REMOVAL THAN LEAVING IT IN PLACE. MEDICAL HISTORY INCLUDED CHRONIC SPASTICITY DUE TO C5-6 QUADRIPLEGIA. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386682 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R