BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4850330 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-11747
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS REPLACED (MFG. REPORT # 3004209178-2015-11738) AND PROGRAMMED AT THE PREVIOUS RATE. IN THE RECOVERY ROOM, THE PATIENT¿S BLOOD PRESSURE ¿PLUMMETED¿ BECAUSE SHE RECEIVED TOO MUCH MEDICATION. THE PROBLEM WAS ¿FIXED¿ AND THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT (ICU). THE NEXT DAY, THE PATIENT WAS FINE AND DISCHARGED. THE DAY AFTER THAT WHILE AT HOME, THE PATIENT TRIED TO WALK AND COULD NOT STAND. THE PATIENT HAD NOT BEEN ABLE TO STAND SINCE. THE PATIENT HAD AN MRI ON (B)(6) 2015 FOR LOWER THE EXTREMITY WEAKNESS EXPERIENCED SINCE PUMP REPLACEMENT. THE PUMP WAS USED TO DELIVER FENTANYL, CLONIDINE, AND BACLOFEN (UNKNOWN). NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393185 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| L| O