BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3091934 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07239
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8 731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4). ALL PREVIOUSLY REPORTED CONCLUSION CODES HAVE BEEN UPDATED/CORRECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS WHEELCHAIR BOUND AND DEVELOPED A DECUBITUS ULCER BELOW THE PUMP SITE. THE PUMP WAS IMPLANTED IN HER BUTTOCKS. THE PATIENT HAD INCISIONAL WOUND OPENING AND DRAINAGE IN THE DEVICE POCKET LOCATION. THE PUMP WAS SURGICALLY REPOSITIONED FROM THE BUTTOCKS AREA, TO THE RIGHT FLANK/ABDOMEN AREA. PER THE PHYSICIAN, THE POCKET DID NOT APPEAR INFECTED AND THE ULCER WAS NOTED TO BE "INCHES" FROM THE PUMP POCKET. THE PATIENT WAS RECEIVING EFFECTIVE DELIVERY OF DRUG PRE AND POST REVISION. THERE WERE NO FURTHER ISSUES REPORTED. THE PATIENT STATUS WAS REPORTED AS "ALIVE - NO INJURY/NO ADVERSE EVENT." THE PUMP WAS DELIVERING INFUMORPH AND BUPIVACAINE.

    Description of Event or Problem · 1

    HE FOLLOWING INFORMATION HAS ALREADY BEEN REPORTED IN MANUFACTURER REPORT # 3004209178-2013-02503: IT WAS REPORTED THAT THERE WAS A "WOUND DEVELOPING AT LOWER EDGE OF PUMP SITE RESEMBLING POSSIBLE MRSA VS. PRESSURE ULCER". THEY WERE UNABLE TO ASPIRATE FLUID AT THE POCKET SITE. INTERVENTIONS HAVE INCLUDED: MEDICATION ADJUSTMENT, SPECIFIC MEDICATION, DOES, AND ROUTE OF ADMINISTRATION. THE PATIENT WAS BEING INFUSED WITH MORPHINE AND BUPIVACAINE VIA THE PUMP. ADDITIONAL INFORMATION REPORTED THE PATIENT HAD A DECUBITUS ULCER ON THE RIGHT BUTTOCKS, NEAR THE PUMP POCKET. IT WAS DETERMINED THERE WAS NOT AN INFECTION BUT AN ULCER, POSSIBLY RELATED TO EXCESS PRESSURE FROM THE PUMP. THE MEDICATION WAS ADJUSTED; AUGMENTIN. THE DEVICE WAS SURGICALLY REPOSITIONED BY MOVING THE PUMP POCKET, ON (B)(6) 2013. A CULTURE OF THE WOUND WAS ALSO DONE. THE RESULTS WERE REPORTED AS ¿POSITIVE RBC¿S, NO ORGANISMS SEEN, NO PMNS AND NO GROWTH.¿ ADDITIONAL INFORMATION REPORTED THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. ANY ADDITIONAL INFORMATION RECEIVED IN REGARDS TO THIS EVENT WILL BE REPORTED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194195 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention