BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201591 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01126
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    January 6, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L60027, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED CONCLUSION CODE 67 NO LONGER APPLIES TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ¿BLOUSED AT A REFILL¿ AND SHE WAS PASSED OUT AFTER THE REFILL. THE REPORTER STATED THAT THE DOCTOR SUSPECTED A CATHETER LEAKAGE. IT WAS NOTED THAT RIGHT AFTER PUMP IMPLANT, THE PATIENT WAS INCOHERENT AND ¿COULD NOT SPEAK OR DO ANYTHING.¿ THE PATIENT OUTCOME WAS UNKNOWN. THE DRUG USED IN THE PUMP WAS UNKNOWN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HCP PUT "DEADLY" DOSES OF MORPHINE IN THE PUMP IN 2007. THE PATIENT REPEATED THAT BLOOD WAS COMING THROUGH HER SKIN. THE CONCENTRATION WAS 50MG/ML AND THE DOSE WAS "ALMOST 6 MG PER DAY." THE PATIENT DISPUTED WITH THE HCP AND "BEGGED" HIM TO LOWER THE MEDICINE AND THIS HAS MADE IT DIFFICULT TO FIND A NEW HCP.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT. THE PATIENT HAD A DOCTOR OVERDOSING HER ON MORPHINE. SHE BEGGED HIM TO TURN THE CONCENTRATION DOWN AND SHE WAS DISMISSED FROM THE DOCTOR. THE PATIENT NEVER HAD HER PUMP OVER 50MG, 25MG OR 20MG. THE PUMP WAS ALWAYS AT 10% AND THEN IT WAS INCREASED TO 20%, WHICH WAS ¿BRINGING BLOOD TO THE SURFACE OF HER SKIN¿. BECAUSE ONE DOCTOR OVERDOSED THE PATIENT, HER OTHER DOCTORS DIDN¿T WANT TO MANAGE HER CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303221 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other