BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 1992626 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-01018
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    July 6, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    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): THE DEVICE WAS RECEIVED AND ANALYZED. THE PRIMARY ANALYSIS RESULTS REVIEWED NO ANOMALIES 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. EVALUATION SUMMARY : (B)(4): THE DEVICE WAS RECEIVED AND ANALYZED. THE PRIMARY ANALYSIS RESULTS REVIEWED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO REPLACE THE LEAD DUE TO APPARENT FRACTURE, THE LEAD WIRE 'HIT' SOME SCAR TISSUE. AS A RESULT, THE PATIENT SUFFERED A HEMOPNEUMOTHORAX, AND WAS TREATED ACCORDINGLY. THE LEAD WAS CAPPED AND REPLACED. THE DEVICE EXHIBITED A LOW BATTERY INDICATOR AND THE WAS COMPLAINED OF BEING "DEFECTIVE." THE DEVICE WAS ALSO 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
    1 ENTRUST AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154ATG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 4472 COMPETITOR IMPLANTABLE LEAD| 4472 COMPETITOR IMPLANTABLE LEAD