BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2844036 · Received November 24, 2012

    Report

    Report Number
    3007566237-2012-02822
    Event Type
    Injury
    Date Received
    November 24, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: DURING THE POCKET REVISION SURGERY, EXCESS SCAR TISSUE WAS REMOVED WHERE THE CATHETER ATTACHED TO THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POCKET REVISION WAS DONE. THE PATIENT HAD A WEIGHT LOSS OF 60 LBS SINCE IMPLANT, AND THE PUMP WAS REPOSITIONED DUE TO BEING CLOSE TO THE SKIN. THE PATIENT INDICATED THAT THE PUMP WAS ONCE AGAIN GETTING CLOSE TO THE SKIN AND WAS GOING TO SPEAK TO THE HEALTHCARE PROVIDER (HCP) REGARDING THIS. FURTHER DETAIL WAS LATER PROVIDED BY THE HCP ABOUT THE PREVIOUS POCKET REVISION. ACCORDING TO THE OPERATIVE NOTE, THE PUMP POCKET SITE WAS UNSTABLE OR PAINFUL, AND THEREFORE, A REVISION OF PUMP POCKET WITH RE-IMPLANTATION OF THE PUMP WAS DONE ON (B)(6) 2011. THE HCP NOTED THAT THE PUMP OVER THE RIGHT HIP HAD BECOME PAINFUL FOLLOWING WEIGHT LOSS, AND DESIRED PUMP POCKET REVISION IN ORDER TO DECREASE PAIN AT THAT SITE. THERE WERE NO PROCEDURE COMPLICATIONS. PUMP WAS REFILLED AND RE-PROGRAMMED DURING THE PROCEDURE. THE MEDICATIONS DELIVERED BY THE PUMP WERE FENTANYL AND BACLOFEN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention