BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 3152367 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-09050
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SAVE TO DISK (STD) REVIEW: NO ANOMALIES WERE FOUND. CONCOMITANT PRODUCTS: 5019 ADAPTOR 2013 (B)(6); 4076 IMPLANTABLE PACING LEAD 2013 (B)(6); 6937A IMPLANTABLE TACHY LEAD 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) DUE TO SHOCKS DELIVERED FROM THE DEVICE FOLLOWING PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND AFTER THE ARRHYTHMIA HAD BROKEN WHICH CONSEQUENTLY PUT THE PATIENT BACK INTO VENTRICULAR TACHYCARDIC A/VENTRICULAR FIBRILLATION (VT/VF.) THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252979 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Life Threatening 6947M IMPLANTABLE TACHY LEAD