BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Q-TRAK SUBCUTANEOUS ELECTRODE

    MDR report key: 2932106 · Received January 25, 2013

    Report

    Report Number
    3009448963-2013-00007
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    CAMERON HEALTH INC
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW, INCLUDING STERILITY RECORDS, FOR THE ELECTRODE AND PULSE GENERATOR WERE CONDUCTED. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    CAMERON HEALTH RECEIVED INFORMATION THAT APPROXIMATELY ONE (1) MONTH AFTER IMPLANT, THE S-ICD SYSTEM (PULSE GENERATOR AND ELECTRODE) WAS EXPLANTED DUE TO POCKET INFECTION. IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY BEEN TREATED WITH ANTIBIOTICS UNSUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE EXPLANT. THE PULSE GENERATOR AND ELECTRODE HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36212 Q-TRAK SUBCUTANEOUS ELECTRODE ELECTRODE LWS CAMERON HEALTH INC 3010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| L| R