BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3212376 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11471
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8711, SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THE CATHETER TO THE PUMP WAS REMOVED BUT THE CATHETER TO THE CSF (CEREBROSPINAL FLUID) REMAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT LEFT THE HOSPITAL AND ¿AT THE EARLY-EVENING¿ HAD A FEVER. ON (B)(6) 2012, THE PUMP AND CATHETER WERE REMOVED AT AN EMERGENCY OPERATION. IT WAS NOTED THE CATHETER REMAINED INTRASPINALLY ¿TO EXTRACT SPINAL FLUID¿. THEN ON (B)(6) 2012, INSPIRATORY STRIDOR, STRONG OPISTHOTONOS AND HIGH ACTIVITIES OF SERUM CREATINE KINASE WERE SEEN. AS A RESULT, ¿THE SYNDROME WAS CONSIDERED WITHDRAWAL EFFECT¿. IT WAS CONSIDERED THAT THE HIGH ACTIVITIES OF SERUM CREATINE KINASE WAS DERIVED FROM THE REMOVAL OF THE PUMP SYSTEM. IT WAS NOTED IT WAS UNCLEAR IF THE GABALON INJECTED INTO THE SPINAL COLUMN WAS RELEVANT TO THE HIGH ACTIVITIES OF SERUM CREATINE KINASE. DANTHRON 10MG WAS ADMINISTERED IN THE MORNING AND THE EVENING. ON (B)(6) 2012, DANTRIUM AND PERIACTIN WERE ADMINISTERED FOR THE WITHDRAWAL EFFECT. THEN ON (B)(6) 2012, THE PATIENT¿S MUSCULAR TONE GRADUALLY IMPROVED AND DECREASED TO CK178 U/L. ON (B)(6) 2012, IT WAS THEN NORMALIZED AT CK82 U/L. AS OF (B)(6) 2012, THE PATIENT¿S MUSCULAR TONE BECAME THE STATE IT WAS BEFORE THE PUMP HAD BEEN IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED, ¿THE CATHETER TO THE PUMP WAS REMOVED BUT CATHETER TO THE CSF (CEREBROSPINAL FLUID) WAS REMOVED¿. IT WAS HOWEVER UNCLEAR WHETHER THE CATHETER WAS EXPLANTED FULLY AS IT THEN WAS INDICATED THAT THERE WAS NO EXPLANT SURGERY PLANNED FOR THE CATHETER IF IT REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313292 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 YR Hospitalization| R