BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 3152878 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08858
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 15, 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
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. NO ANOMALIES WERE FOUND. THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED SHORTING/LOW IMPEDANCE IN THE HYBRID.

    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: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. NO ANOMALIES WERE FOUND. CONCOMITANT PRODUCTS 1342 COMPETITOR IMPLANTABLE PACING LEAD - 2002-(B)(6), 1346T COMPETITOR IMPLANTABLE PACING LEAD - 2002-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A RAPID BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A RAPID BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255673 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R 1590 COMPETITOR IMPLANTABLE TACHY LEAD