BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2201779 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11193
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    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 PATIENT WAS SHOCKED DUE TO T-WAVE OVERSENSING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SHOCKED DUE TO T-WAVE OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY REPORTED THAT THE LEAD WAS REPROGRAMMED AND REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB