BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBQ

    MDR report key: 2812777 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03750
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBCUTANEOUS LEAD WAS FRACTURED. THE LEAD WAS PARTIALLY REMOVED AND NOT REPLACED. NO PATIENT COMPLICATION HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBCUTANEOUS LEAD WAS FRACTURED. THE LEAD WAS PARTIALLY REMOVED AND REPLACED. NO PATIENT COMPLICATION HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBQ IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6996

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R 1580 COMPETITOR IMPLANTABLE TACHY LEAD| (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| UNK COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 1056T COMPETITOR IMPLANTABLE PACING LEAD