BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2181277 · Received July 21, 2011

    Report

    Report Number
    3004209178-2011-05629
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S POCKET WAS ISCHEMIC. THE MANAGING PHYSICIAN INITIALLY PLANNED TO MOVE THE DEVICE POCKET TO THE OPPOSITE SIDE OF THE PT'S BODY, AND PLACE A NEW CATHETER "HIGHER". THE PHYSICIAN, HOWEVER, CHANGED THEIR PLAN, AND HAD EXPLANTED ALL PRODUCTS DUE TO CONCERN OVER SKIN BREAKDOWN AND POTENTIAL INFECTION. THE DECISION WAS MADE TO NOT RE-IMPLANT AT THIS TIME. THE PT WAS WITHOUT INJURY, AND HAD RECOVERED FROM THE EXPLANT PROCEDURE WITHOUT SEQUELAE. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N247103002| EXPLANTED: