BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203567 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-00490
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    July 10, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703W, LOT# L46104, IMPLANTED: (B)(6) 1998. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO MONTHS PRIOR TO THE DATE OF THIS REPORT THE PATIENT HEARD A PUMP ALARM AND STARTED TO GO INTO WITHDRAWALS. THE PATIENT WENT IN FOR A REFILL AND IT WAS UNCLEAR WHAT TROUBLESHOOTING TOOK PLACE. IT WAS REPORTED THAT THE PATIENT¿S ELECTIVE REPLACEMENT INDICATOR (ERI) WAS IN FOUR MONTHS. IT WAS PLANNED TO REPLACE BOTH THE PUMP AND THE CATHETER. THE PATIENT WAS NERVOUS THAT THE PHYSICIAN WAS WAITING UNTIL THE LAST MINUTE TO REPLACE THE DEVICE. THE PUMP WAS USED TO DELIVER CLONIDINE, BACLOFEN, DILAUDID, AND MARCAINE. ADDITIONAL INFORMATION STATED THAT JUST THE PUMP WAS EXPLANTED. THE PUMP WAS REPLACED DUE TO A NORMAL LOW BATTERY ALARM OCCURRING. THE PATIENT HAD ¿NO INJURY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306449 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Other