BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2835223 · Received November 16, 2012

    Report

    Report Number
    3004209178-2012-10368
    Event Type
    Injury
    Date Received
    November 16, 2012
    Report Date
    October 25, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMER: MODEL 8835, SERIAL# (B)(4), IMPLANTED: NA, EXPLANTED:NA, CATHETER: MODEL 8709, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED INCREASED PAIN; SEVERITY MILD. THE DRUG INFUSION RATE WAS INCREASED BETWEEN MAY AND SEPTEMBER (ON (B)(6) 2012- 50% INCREASE IN INFUSION RATE, (B)(6) 2012 - 33%, (B)(6) 2012 - 25%, (B)(6) 2012 - 31% AND ON (B)(6) 2012- 15% INCREASE IN INFUSION RATE). ON (B)(6) 2012 AN X-RAY WAS DONE THAT SHOWED CATHETER DISCONNECT FROM PUMP. THE CATHETER WAS REPLACED ON (B)(6) 2012. PATIENT OUTCOME WAS INDICATED AS RECOVERED WITHOUT SEQUELA. THE SYSTEM WAS USED TO INFUSE DILAUDID, BUPIVACAINE, DROPERIDOL. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention