BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2082800 · Received May 3, 2011

    Report

    Report Number
    3004209178-2011-03209
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    June 1, 2010
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED AN ALARM WAS HEARD, BUT THE PHYSICIAN WAS UNABLE TO OBTAIN TELEMETRY WHEN THE PATIENT CAME TO THE PHYSICIAN'S OFFICE. THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS. THE PATIENT HEARD THE ALARM FOR APPROXIMATELY 1.5 WEEKS BUT DID NOT REALIZE THE SOUND WAS COMING FROM THE PUMP. IT WAS LATER REPORTED THE PUMP "WAS FINE." THERE WAS "NO PROBLEM" INTERROGATING THE PUMP. IT WAS BELIEVED THERE COULD HAVE BEEN A PROGRAMMER USE ISSUE WHEN TELEMETRY COULD NOT BE OBTAINED EARLIER. THE PUMP WAS REPLACED WITH A SMALLER 20 ML PUMP ONLY BECAUSE THE PATIENT WANTED A SMALLER PUMP; THERE WAS NO ISSUE WITH THE PUMP. THE PUMP WAS NOT ALARMING WHEN INTERROGATED. NO EVENT LOGS WERE AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 INDICATED THE PUMP CONTAINED MORPHINE. THE PATIENT EXPERIENCED INCREASED PAIN. THE REPORTER INDICATED THE ISSUE WITH THE PUMP WAS "PREMATURE BATTERY DEPLETION." THE BATTERY ISSUE WAS "POSSIBLY DUE TO ELECTROCAUTERY FOR ANOTHER SURGICAL PROCEDURE. A (B)(6) STUDY REVEALED AN INTACT CATHETER. FOLLOWING PUMP REPLACEMENT, THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention CATHETER: MODEL 8578, LOT# N114733| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N106580015| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK