BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032365 · Received March 28, 2011

    Report

    Report Number
    3004209178-2011-02326
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD A BLOCKAGE. DRUG WAS NOT FLOWING IN THE PUMP. DEVICE INTERROGATION REVEALED THAT THE MOTOR STALLED. THE PUMP WAS USED TO DELIVER MORPHINE. THE PATIENT EXPERIENCED PAIN ASSOCIATED WITH THE EVENT THOUGH SHE WAS PROVIDED CONVENTIONAL TREATMENTS. THE PUMP WAS EXPLANTED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention CATHETER: MODEL 8731SC, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: