BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 9198678 · Received October 16, 2019

    Report

    Report Number
    3004209178-2019-19765
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Report Date
    October 16, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100831
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, LOT#: J0058223R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT #: (B)(4), UBD: 2003-03-06, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING AN UNKNOWN DRUG OF UNKNOWN CONCENTRATION AT AN UNKNOWN DOSE RATE VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY, CEREBRAL PALSY, AND OTHER. IT WAS REPORTED THAT THE PATIENT WAS NEEDING A BRAIN MRI (MAGNETIC RESONANCE IMAGING). THE PATIENT HAD AN ABDOMINAL X-RAY PERFORMED ON (B)(6) 2019 AND IT WAS DISCOVERED THAT A FRAGMENT OF THE CATHETER HAD BROKEN OFF AND WAS IN THE SPINAL CANAL. THE DATE OF THE EVENT WAS UNKNOWN. THE HCP WAS QUESTIONING HOW THIS MAY AFFECT MRI COMPATIBILITY. NO PATIENT SYMPTOM WAS REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989692 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1