BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR

    MDR report key: 6165464 · Received December 11, 2016

    Report

    Report Number
    9612355-2016-00066
    Event Type
    Injury
    Date Received
    December 11, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 29, 2016
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS NOT MDR REPORTABLE AND WAS SUBMITTED IN ERROR. DUE TO TESTING OF A NEW SYSTEM, THIS REPORT WAS ACCIDENTALLY REPORTED TO THE FDA AS A REPORTABLE EVENT WHEN IT IS NOT A REPORTABLE EVENT AND ONLY A TEST SUBMISSION. THE ISSUE OF THIS COMPLAINT IS FOR NOISE. THIS EVENT IS NOT MDR REPORTABLE BECAUSE THE PHYSICIAN DID HAVE AT LEAST ONE ELECTROCARDIOGRAM SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM, THEREFORE THE RISK TO THE PATIENT IS LOW. FAN WAS FOUND LOOSE AND NIS AND MDV WERE OUT OF CALIBRATION. FAN WAS TIGHTENED. NIS AND MDV BOARDS WERE RECALIBRATED AS PART OF THE PREVENTATIVE MAINTENANCE. SAFETY TESTS PERFORMED. UNIT WAS FOUND FULLY FUNCTIONAL AND IS READY FOR USE.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS TO ESTABLISH THIS REPORT WAS SUBMITTED IN ERROR AND THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THE ISSUE OF THIS COMPLAINT IS FOR NOISE. THIS EVENT IS NOT MDR REPORTABLE BECAUSE THE PHYSICIAN DID HAVE AT LEAST ONE ELECTROCARDIOGRAM SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM, THEREFORE THE RISK TO THE PATIENT IS LOW. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT DURING A ABLATION OF ATRIAL TACHYCARDIA PROCEDURE, THERE WAS NOISE ON ABLATION, CUSTOMER CHANGED ALL CABLES AND PROBLEM PERSISTED. SWITCHED TO ANOTHER STOCKERT GENERATOR AND NOISE ISSUE WAS RESOLVED. STOCKERT WILL BE SENT FOR REPAIR. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815716 STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR SIMILAR DEVICE S7001, PMA # P990071 LPB STOCKERT GMBH 39D-76X

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O