BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2234248 · Received August 25, 2011

    Report

    Report Number
    3004209178-2011-06854
    Event Type
    Death
    Date Received
    August 25, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2381-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN ELECTIVE PUMP REPLACEMENT DUE TO PUMP SIZE. ON (B)(6) 2011, THE PATIENT UNDERWENT THE PUMP REPLACEMENT SURGERY. THE PHYSICIAN DID NOT ASPIRATE THE CATHETER PERI-OPERATIVELY. THE CATHETER WAS DISCONNECTED FROM THE OLD PUMP AND CLAMPED. THE NEW PUMP WAS FILLED WITH DRUG (LIORESAL) AND AFTER A PURGE BOLUS OF THE PUMP TUBING, THE NEW PUMP WAS CONNECTED TO THE IMPLANTED CATHETER. ON (B)(6) 2011, THE PATIENT EXPERIENCED INCREASED SPASTICITY. ON (B)(6) 2011, THE PATIENT EXPERIENCED "RESPIRATORY INSUFFICIENCY (OVERDOSAGE SYMPTOM)". SURGICAL INTERVENTION WAS PERFORMED; THE PHYSICIAN OPENED THE INCISION AND NOTED THERE WAS A VISIBLE LEAK BETWEEN THE CONNECTOR AND THE PUMP. THE PHYSICIAN STATED THAT IT LOOKED LIKE CEREBROSPINAL FLUID (CSF). THE PHYSICIAN PERFORMED A RE-CONNECTION, THE "LEAKAGE SOLVED", AND THE INCISION WAS CLOSED. ON (B)(6) 2011 THE ICU DIAGNOSED MULTIPLE ORGAN FAILURE (MOF) FOR THE PATIENT. ON (B)(6) 2011, THE PATIENT EXPIRED DUE TO MOF. PER THE REPORT, THE "...PHYSICIAN STATED THAT MOF WAS NOT RELATED TO MDR SYSTEM". THE DEVICES REMAINED IMPLANTED; PUMP PRINTOUTS WERE NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R