BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA VR

    MDR report key: 1802951 · Received August 17, 2010

    Report

    Report Number
    6000144-2010-04207
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 29, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 FOUND, HOWEVER GROMMET DAMAGE WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING DEVICE CHANGE THERE WAS NOISE ON THE LEAD, HIGH IMPEDANCE GREATER THAN 3000 OHMS, AND A SIGNIFICANT THRESHOLD RISE. THE LEAD TESTED OK ON THE ANALYZER. THE DEVICE WAS EXPLANTED AND REPLACED. THE IMPEDANCE WAS STILL GREATER THAN 3000 OHMS THROUGH THE NEW DEVICE, SO THE LEAD WAS CAPPED 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
    1 SECURA VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention