BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2120019 · Received June 8, 2011

    Report

    Report Number
    3007566237-2011-04131
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S PTM (PERSONAL THERAPY MANAGER) WAS DISPLAYING AN ERROR CODE. THE PT CONTACTED HER PHYSICIAN AND WAS ADMITTED TO THE HOSPITAL LATER THAT NIGHT. THE PUMP WAS INTERROGATED THE NEXT DAY. THE PUMP LOGS INDICATED THAT A PUMP STALL RECOVERED. THE PT WAS DISCHARGED TO HOME. ON (B)(6) 2011, THE PT CONTACTED THE PHYSICIAN BECAUSE THE PUMP WAS ALARMING. THE PT WAS SCHEDULED FOR REPLACEMENT SURGERY. THE PUMP WAS REPLACED. THERE WAS REPORTED TO BE NO PT INJURY. THE PT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE (40 MG/ML, 4.502 MG/DAY) AND MARCAINE (2.5 MG/ML, 0.2814 MG/DAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXPLANTED:| PROGRAMMER: MODEL PTM, LOT# UNK| IMPLANTED: