BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3233846 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11970
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - (CO2 RETENTION/HYPERCAPNIA).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8578 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT FOLLOWING THE REPLACEMENT THE PATIENT EXPERIENCED INCREASED LETHARGY AND CARBON DIOXIDE RETENTION. THE PATIENT WAS HOSPITALIZED. IT WAS NOTED THAT CREATING A NEW CATHETER CONNECTION (REFER TO MANUFACTURER REPORT # 3007566237-2013-02402) ALLOWED BETTER FLOW AND RESULTED IN OVERDOSE. A CT HEAD IMAGING SHOWED NO CHANGES. THE DOSE WAS DECREASED FROM 900MCG/DAY TO 96.1MCG/DAY ON (B)(6) 2013. THE REPORTER ALSO NOTED THAT THE PATIENT WAS NEVER COMATOSE. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. THE DEVICE SYSTEM DELIVERED GABLOFEN. IT WAS LATER REPORTED THAT THE CT IMAGING WAS TAKEN ON (B)(6). THE PATIENT EXPERIENCED HYPERCAPNIA AND WAS GIVEN A BIPAP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS OVERDOSED AND WENT INTO A COMA FOR 1-3 DAYS AFTER AN IMPLANT OF A NEW PUMP (REFER TO MANUFACTURER REPORT # 3007566237-2013-02402 FOR REASON FOR PUMP REPLACEMENT). THE PATIENT HAD BEEN IN THE HOSPITAL FOR ¿SEVERAL¿ WEEKS AND HAD RECENTLY BEEN RELEASED. THE PATIENT WAS NO LONGER ABLE TO STAY HOME ALONE AND COULD NOT TAKE CARE OF HERSELF. THE PATIENT¿S MOTHER WAS VERY FRUSTRATED AS NO ONE "SEEMED TO CARE" THAT THE PATIENT WAS NOT ABLE TO FUNCTION LIKE BEFORE THE IMPLANT. THE PATIENT COULD EVENTUALLY FUNCTION ON HER BUT HER CAPACITY WAS DIMINISHED FROM WHAT IT WAS PRIOR TO THE PUMP REPLACEMENT. IT WAS STATED "I GUESS THERE¿S QUESTIONS ABOUT HOW MUCH DAMAGE MIGHT HAVE BEEN DONE THROUGH THIS INCIDENT". A THERAPIST WAS COMING DAILY TO WORK WITH THE PATIENT. THE DRUG BEING INFUSED WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT, FOLLOWING THE REPLACEMENT (REFER TO MANUFACTURER REPORT # 3007566237-2013-02402), THE DOSE WAS RESUMED AT THE SAME RATE. IT REPORTEDLY RELAXED THE PATIENT¿S HEART AND LUNG MUSCLES; THE PATIENT WASN¿T WAKING UP AND ALMOST DIED. AT THE TIME OF THE EVENT, THE PATIENT WAS RECEIVING 900MCG PER DAY OF GABLOFEN 2,000MCG/ML. NO FURTHER NEW INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334518 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Hospitalization| L| R