BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1978615 · Received February 1, 2011

    Report

    Report Number
    3007566237-2011-00759
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    June 9, 2005
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8637-20, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE PUMP; PRODUCT ID 8637-20, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2011, PRODUCT TYPE PUMP; PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER; PRODUCT ID 8596, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8731, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE "WRONG PUMP" WAS SENT AND IMPLANTED. THE PUMP WAS TOO LARGE AND STICKING OUT OF THE PATIENT'S BODY.

    Description of Event or Problem · 1

    THE PUMP WAS TOO LARGE FOR THE PT AND KEPT FLIPPING. THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention EXPLANTED:| LOT# NGP349551H| SEE H10| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# B005645N30| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-20,| EXPLANTED:| IMPLANTED:| LOT# NGP013926N| IMPLANTABLE INFUSION PUMP: MODEL 863720,