BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNCHROMED II

    MDR report key: 1160011 · Received September 12, 2008

    Report

    Report Number
    3004209178-2008-05680
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO/
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, IMPORTANT INFORMATION ON POTENTIAL MRI EFFECTS, PHYSICIAN COMMUNICATION (2008).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE PATIENT HAD PREVIOUSLY HAD A MRI. AFTER RE-INTERROGATING WITH THE LOG MOTOR STALL RECOVERY WAS RECORDED. THE PATIENT WAS ASYMPTOMATIC. IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED AT THE TIME OF THE EVENT. THE PATIENT WAS HOSPITALIZED FOR BED SORES. THE DRUG CONTAINED IN THE PATIENT'S PUMP WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO/ 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709SC| EXPLANTED: