BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190337 · Received July 25, 2011

    Report

    Report Number
    3004209178-2011-05746
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    April 29, 2008
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT EXPERIENCED SEVERE WITHDRAWAL SYMPTOMS AND SUBSEQUENT ATTEMPT TO FIND THE PROBLEM LED TO AN OVERDOSE. THE PATIENT WAS IN GREAT PAIN FOR OVER THREE WEEKS AND STATED THE "PUMP HAD FAILED SOMEHOW." THE FIRST PUMP HAD LASTED FOR OVER 5 YEARS AND THE PATIENT WAS VERY APPRECIATIVE OF THE DEVICE, "IT HAS FRANKLY GIVEN ME MY LIFE BACK THESE PAST 8 YEARS." PRESENTLY THE PATIENT WAS "PRETTY SHAKEN, HURT AND SCARED." THE NEXT PHYSICIAN VISIT WAS SCHEDULED ON (B)(6) 2011. THE DRUG(S) INFUSED VIA THE PUMP: UNK. 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 LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other EXPLANTED:| CATHETER: MODEL 8709, LOT# J11430R43| LOT# NGH032337R| IMPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8627L18