BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5526359 · Received March 25, 2016

    Report

    Report Number
    3004209178-2016-05393
    Event Type
    Injury
    Date Received
    March 25, 2016
    Date of Event
    December 30, 2015
    Report Date
    November 4, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA PRODUCT SURVEILLANCE REGISTRY (PSR) INDICATED THERAPY WAS SUSPENDED ON (B)(6) 2015 AND THERAPY WAS RESUMED ON (B)(6) 2016. THE EVENT WAS RELATED TO THE INTRATHECAL MEDICATIONS HYDROMORPHONE AND BACLOFEN. THE PATIENT REPORTS FEELING 'OVER-MEDICATED' FOLLOWING THE INTRATHECAL (IT) DOSE INCREASE THE PREVIOUS DAY. THE PATIENT'S PUMP WAS PROGRAMMED TO MINIMAL RATE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA PSR (PRODUCT SURVEILLANCE REGISTRY) REGARDING A PATIENT WHO WAS RECEIVING DILAUDID 750.0 MCG/ML; 36.01 MCG/DAY, COMPOUNDED BACLOFEN 350.0 MCG/ML; 16.80 MCG/DAY AND BUPIVACAINE 30.0 MG/ML; 1.440 MG/DAY VIA AN IMPLANTABLE PUMP FOR MALIGNANT PAIN AND HEAD/NECK (NON-MALIGNANT). IT WAS INDICATED THAT THE CONCOMITANT MEDICATION TAKEN AT THE TIME OF THE EVENT ((B)(6) 2015) WAS PERCOCET. INFUSION MODE WAS SIMPLE CONTINUOUS AND PATIENT ACTIVATION WAS ENABLED. PROGRAMMING DATE FROM MOST RECENT REFILL PRIOR TO EVENT WAS (B)(6) 2015. THE PUMP WAS REPROGRAMMED (B)(6) 2015 87 % DECREASE DILAUDID 750.0 MCG/ML; 4.57 MCG/DAY, BACLOFEN 2.13 MCG/DAY; 16.80 MCG/DAY AND BUPIVACAINE 30.0 MG/ML; 0.183 MG/DAY. THE DATE OF THE EVENT WAS (B)(6) 2015. IT WAS REPORTED THE PATIENT EXPERIENCED INTRATHECAL MEDICATION SIDE EFFECTS. ON (B)(6) 2015 THE PATIENT REPORTED FEELING 'OVER-MEDICATED'. THE SPECIFIC SYMPTOMS WERE UNKNOWN. THE EVENT RESULTED IN THE UNSCHEDULED CLINIC OR OFFICE VISIT. ETIOLOGY WAS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. ETIOLOGY WAS RELATED TO HYDROMORPHONE. DRUG ACTION THAT CAUSED THE EVENT WAS A DOSE INCREASE. THE OUTCOME RESOLVED WITHOUT SEQUELAE (B)(6) 2016.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA PSR (PRODUCT SURVEILLANCE REGISTRY) INDICATING THE PATIENT'S PAST MEDICAL/SURGICAL HISTORY INCLUDED HEADACHE, MIGRAINE (B)(6) 2015, TUMOR SURGERY 2014, TUMOR REMOVAL (B)(6) 2008, HIGH HERNIA REPAIR 2007, THROAT SURGERY 2006, HYSTERECTOMY 1982, HERNIA REPAIR 2007, AND A KNEE REPLACEMENT 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183173 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Other