BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201446 · Received July 2, 2013

    Report

    Report Number
    3004209178-2012-12115
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2012
    Report Date
    November 8, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N138647, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IS NO LONGER APPLICABLE TO THE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NUMBNESS FROM THE WAIST DOWN AND BACK SPASMS. SYMPTOMS OCCURED DAILY FOR 3 HOUR PERIODS AND THEN SUBSIDED. SPASMS ALSO OCCURRED IN THE PATIENT¿S GROIN AREA. THE PATIENT WENT TO THE EMERGENCY ROOM AND HAD A COMPUTED TOMOGRAPHY (CT) SCAN THAT SHOWED THAT THE PUMP WAS ¿FINE.¿ THERE WAS NO GRANULOMA. IT WAS SUSPECTED THAT THE PUMP MIGHT BE LEAKING, BUT THIS HAD NOT BEEN CONFIRMED. THERE WAS A REFILL DONE TO SWITCH MEDICATIONS. THERE WERE 5 CCS OF MEDICATION IN THE PUMP, BUT THERE WAS SUPPOSED TO BE ¿14 OR 20¿ CCS. THE MEDICATION WAS SWITCHED FROM BUPIVACAINE AND DILAUDID TO JUST DILAUDID. THE PATIENT DID NOT EXPERIENCE NUMBNESS SINCE REMOVING THE BUPIVACAINE FROM THE PUMP, BUT THE SPASMS CONTINUED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THE PUMP HAD TO BE REPLACED BECAUSE IT WAS "LEAKING". EVERY TIME THE PATIENT WOULD LAY ON HIS LEFT SIDE, THE LEFT SIDE OF HIS BODY WOULD GO NUMB. ONE TIME, THE PATIENT WAS COMPLETELY NUMB FROM THE CHEST DOWN. THIS HAPPENED A COUPLE MONTHS BEFORE THE PUMP WAS REPLACED. NO OUT OF BOX FAILURE WAS REPORTED. NO MEDICAL OR THERAPY PROBLEM ASSOCIATED WITH SMALL PARKS WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301683 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention