BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2160932 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-04520
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PUMP ALARM WAS HEARD. TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING. THE ALARM WAS DUE TO A PUMP MEMORY ERROR. THE PUMP LOGS NOTED PUMP IN SAFE STATE/RESET ON (B)(6) 2011. THE PATIENT HAD NOT BEEN NEAR ANY SOURCES OF EMI OR UNDERGONE AN MRI. NO REPROGRAMMING HAD BEEN DONE ON THE DATE OF THE MEMORY ERROR. THE PHYSICIAN TRIED TO REPROGRAM THE PUMP TO THE ORIGINAL SETTINGS, BUT THE PUMP WOULD NOT UPDATE. A PUMP REPLACEMENT WAS PLANNED. THE PATIENT WAS NOT EXPERIENCING ANY RETURN OF SYMPTOMS AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, 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 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N220664008| EXPLANTED: