BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2000304 · Received February 17, 2011

    Report

    Report Number
    3004209178-2011-01178
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    September 21, 2010
    Report Date
    July 26, 2025
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A FEW DAYS AFTER PUMP REPLACEMENT (SEE MFR'S REPORT # 6000030-2010-08208), THE PT EXPERIENCED WITHDRAWAL; THE PT DID NOT HAVE WITHDRAWAL WITH THE PRIOR PUMP. IT WAS NOTED THAT THE PT HAD FALLEN MULTIPLE TIMES AND THE PUMP NEVER TREATED HIS LOWER BACK PAIN; THE PT BELIEVED THAT THE CATHETER MAY NOT BE WORKING. THE PUMP HAD BEEN TURNED OFF FOR THE PAST COUPLE OF MONTHS. THE PT WAS LOOKING FOR A PAIN MANAGEMENT DOCTOR. FOUR DAYS LATER, IT WAS REPORTED THAT THE PUMP WAS PROGRAMMED OFF DUE TO A CATHETER LEAK AND/OR PNEUMONIA; THE PT WAS UNSURE. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. ADDITIONAL INFO HAS BEEN REQUESTED A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 81 YR Male CATHETER: MODEL 8575, LOT # N256629| CATHETER: MODEL 8709, LOT # L57101| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8617L18, | IMPLANTABLE INFUSION PUMP: MODEL 8627-18, | IMPLANTABLE INFUSION PUMP: MODEL 8637, | IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LOT # N193164| LOT # NDA007671R| LOT # NGF035916R| LOT # NGP348211H| UNKNOWN CONVERSION TYPE: MODEL 8590-9, | EXPLANTED:| LOT # N193164| IMPLANTED:| CATHETER: MODEL 8709, LOT # L57101| UNKNOWN CONVERSION TYPE: MODEL 8590-9,| IMPLANTED:| EXPLANTED:| IMPLANTED:| LOT # NGF035916R| LOT # NGP348211H| IMPLANTABLE INFUSION PUMP: MODEL 8627-18,| IMPLANTABLE INFUSION PUMP: MODEL 8637,| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8575, LOT # N256629| EXPLANTED:| IMPLANTED:| LOT # NDA007671R| IMPLANTABLE INFUSION PUMP: MODEL 8617L18,| EXPLANTED:| IMPLANTED: