BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2853240 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-10998
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IN THE PAST" THE PATIENT'S DOSE WAS TURNED UP TOO HIGH. THE PATIENT STATED, "I'VE HAD A LITTLE BIT OF TROUBLE WITH THE PUMP REGULATING IT," FURTHER STATING "THEY TURNED IT UP TOO HIGH AND I WENT TO A VEGETABLE." PATIENT THEN STATED THAT IT WAS BEING WORKED OUT AND LATER REPORTED THAT THERE WERE NO CONCERNS WITH THE DEVICE OR THERAPY. IT WAS NOT CLEAR IF THE EVENT WAS DUE TO DOSAGE REGULATING OR A PROGRAMMING ERROR BY THE HEALTHCARE PROVIDER (HCP). THE MEDICATION IN THE PUMP WAS BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ANESTHESIA OR SEDATION FROM A MELANOMA REMOVAL WAS THE CAUSE OF THE EVENT. THE EVENT WAS NOT ATTRIBUTABLE TO ANY OF THE DEVICES OR PROGRAMMING. THE PATIENT DID NOT WAKE UP FROM ANESTHESIA POST-PROCEDURE FOR 2 DAYS FROM EXTENDED SEDATION. IT WAS UNKNOWN WHICH ANESTHESIA MEDICATIONS WERE USED. THE PATIENT WAS HOSPITALIZED AND THERE WAS NO PATIENT INJURY. THE PUMP SYSTEM WAS BEING USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention