BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO DR

    MDR report key: 1926470 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02327
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR, THE LEAD INTEGRITY ALERT HAD TRIPPED, AND THE LEAD HAD OVERSENSING, NOISE, AND INCREASED IMPEDANCE. IT WAS NOTED THAT IN 2005, ONCE, THE LEAD ALSO HAD OVERSENSING AND INCREASED IMPEDANCE. AT EXPLANT IT WAS NOTED THERE WAS BLOOD IN THE CONNECTOR BLOCK AND THAT THE LEAD WAS NOT FULLY CONNECTED TO THE DEVICE. THE DEVICE WAS EXPLANTED AND THE LEAD WAS CONNECTED TO THE NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7278 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD