BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4365277 · Received December 29, 2014

    Report

    Report Number
    3004209178-2014-24576
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Report Date
    December 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. PRODUCT ID: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, LOT# J0177999R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED MORE SPASMS IN THE LEFT LEG COMPARED TO THE RIGHT LEG. THE PATIENT USES A CANE MOST OF THE TIME. A HEALTHCARE PROFESSIONAL (HCP) LATER REPORTED THAT THE PATIENT EXPERIENCED INCREASED SPASTICITY, THOUGH NOT CONSISTENTLY. THE PUMP HAD BEEN STALLING MORE FREQUENTLY SINCE (B)(6) 2014. THE LOGS REVEALED THE FOLLOWING: A NORMAL STALL WITH RECOVERY DUE TO MRI ON (B)(6); A NINE MINUTE STALL WITH RECOVERY ON (B)(6); A NINETEEN MINUTE STALL WITH RECOVERY ON (B)(6); A FIVE MINUTE STALL WITH RECOVERY ON (B)(6); A FIFTEEN MINUTE STALL WITH RECOVERY ON (B)(6); A FIVE MINUTE STALL WITH RECOVERY ON (B)(6); A THIRTY-FIVE MINUTE STALL WITH RECOVERY ON (B)(6); A NINE MINUTE STALL WITH RECOVERY ON (B)(6); A NINETEEN MINUTE STALL WITH RECOVERY ON (B)(6); AND A SEVEN MINUTE STALL WITH RECOVERY ON (B)(6). THEY INITIALLY THOUGHT THE STALLS WERE RELATED TO A MAGNET, BUT THEY DID NOT OCCUR AT THE CORRECT TIMES. THERE WAS REPORTEDLY NO RHYME OR REASON TO THE STALLS. THE PATIENT¿S PUMP CONTAINED LIORESAL BETWEEN (B)(6) 2014. THE PUMP CONTAINED GABLOFEN. THE LOG NOTES INDICATED THE PUMP CONTAINED LIORESAL AS EARLY AS (B)(6) 2014. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855283 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR