BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO DR

    MDR report key: 3152662 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-09016
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO REUSE THE EXISTING DEVICE, BUT THE SETSCREW WOULD NOT ENGAGE ONTO THE NEWLY IMPLANTED COMPETITOR LEAD. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252260 MAXIMO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7278

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6949 IMPLANTABLE TACHY LEAD