BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2010548 · Received March 1, 2011

    Report

    Report Number
    3004209178-2011-01505
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 1, 2010
    Report Date
    February 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE REPORTER, THE PATIENT'S BODY "REJECTED" THE PUMP. FURTHER DETAILS REGARDING THE PUMP REJECTION WERE NOT REPORTED. THE PHYSICIAN REMOVED THE PUMP. A PUMP WAS IMPLANTED ON THE LEFT SIDE OF THE BODY INSTEAD OF THE RIGHT. THE PUMP MEDICATION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8598A, LOT# N174571001| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N197955010