BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 1991064 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00822
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAID THAT HE HAS "PAIN" AROUND THE DEVICE THROUGHOUT THE DAY AND HAS BEEN ONGOING SINCE HE HAD THE DEVICE IMPLANTED. IT WAS ALSO REPORTED THAT THE DEVICE SHOCKED THE PATIENT. THE PATIENT STATED THAT HE RECEIVED AN ELECTRIC SHOCK FROM STATIC ELECTRICITY WHEN HE TOUCHED HIS CHEST AND THAT 15 HOURS LATER THE SKIN OVER HIS ICD SEEMED SWOLLEN. THE DEVICE REMAINS IN USE. 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 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other 6935 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD