BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1892221 · Received November 2, 2010

    Report

    Report Number
    3004209178-2010-08773
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 8, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HCP THAT FOLLOWING AN UNRELATED SURGERY THERE WERE SOME "WEIRD SYMPTOMS". THEY WERE UNSURE OF THE CAUSE AND TRYING TO ELIMINATE A PROBLEM WITH THE PUMP/CATHETER AS A POSSIBILITY. LOGS WERE NORMAL. IT WAS REPORTED ON (B)(6) 2010 THAT A CATHETER REVISION WAS DONE ON A PT THAT UNDERWENT SOME LASER SURGERY RECENTLY. THE LASER APPARENTLY SEVERED THE CATHETER AND THE PT WENT THROUGH WITHDRAWAL. WHEN THE PHYSICIAN OPENED THE CATHETER ENTRY SITE, HE FOUND THE CATHETER HAD BEEN SEVERED RIGHT THROUGH THE ANCHOR. HE COULD NOT LOCATE THE SPINAL PART OF THE CATHETER AND HAD TO ASSUME IT WAS IN THE INTRATHECAL SPACE. HE INSERTED ANOTHER SPINAL CATHETER AND RECONNECTED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR IMPLANTED:| CATHETER: MODEL 8709, LOT# L78692| EXPLANTED: