BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3082249 · Received April 29, 2013

    Report

    Report Number
    3007566237-2013-01454
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED DATE: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A "MORPHINE PUMP" AND PATIENT BECAME ALLERGIC TO THE MORPHINE AND THE PUMP WAS EXPLANTED. PER REPORTER THE EXPLANT WAS ABOUT TWO YEARS AGO AND PATIENT DOES NOT HAVE ANY DEVICE IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THERE WAS NOTHING WRONG WITH THE IMPLANTED DEVICE SYSTEM. PATIENT WANTED MRIS DONE FOR HER TO HAVE SURGERY AND FOR THIS REASON THE SYSTEM WAS REMOVED. PATIENT HAD NO SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185619 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention