BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 3279631 · Received August 10, 2013

    Report

    Report Number
    3004209178-2013-13963
    Event Type
    Injury
    Date Received
    August 10, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD - (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PATIENT WAS INDUCED BY T-SHOCK INDUCTION, HOWEVER, THE DEVICE DID NOT DETECT OR TREAT THE ARRHYTHMIA. THE PATIENT WAS SUBSEQUENTLY CARDIOVERTED EXTERNALLY, AND THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PATIENT WAS INDUCED BY T-SHOCK INDUCTION, HOWEVER THE DEVICE DID NOT DETECT OR TREAT THE ARRHYTHMIA. THE PATIENT WAS SUBSEQUENTLY CARDIOVERTED EXTERNALLY, AND THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384087 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| R 6947M IMPLANTABLE TACHY LEAD