BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 4192969 · Received October 22, 2014

    Report

    Report Number
    9612355-2014-00048
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE SEARCHED AND FOUND THAT THIS STOCKERT WAS MANUFACTURED BEFORE SEPTEMBER 24, 2014, THEREFORE, NO UDI IS NOT APPLICABLE FOR THIS PRODUCT WITH SERIAL NUMBER (B)(4). EVALUATION SUMMARY. (B)(4). IT WAS REPORTED THAT A PATIENT, UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE WITH A STOCKERT 70 RF GENERATOR AND THE ABLATION FOOT PEDAL GOT STUCK. THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. REPAIR FOLLOW-UP WAS PERFORMED AND NO RESPONSES FROM CUSTOMER. SERVICE WAS DECLINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE WITH A STOCKERT 70 RF GENERATOR AND THE ABLATION FOOT PEDAL GOT STUCK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR-LIKE DEVICE WITHOUT PATIENT CONSEQUENCE. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE BECAUSE AN ISSUE OF THIS TYPE COULD POTENTIALLY CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672403 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1