BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SQ-RX PULSE GENERATOR

    MDR report key: 2875256 · Received December 13, 2012

    Report

    Report Number
    3009448963-2012-00005
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 13, 2012
    Manufacturer
    CAMERON HEALTH INC
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY CAMERON HEALTH'S QUALITY LABORATORY ON (B)(6) 2012. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    CAMERON HEALTH RECEIVED INFORMATION THAT 1 YEAR, 16 DAYS AFTER IMPLANT, THE PATIENT PRESENTED TO THE CLINIC AFTER AN AUDIBLE TONE WAS HEARD. WHEN A CONNECTION WAS ESTABLISHED WITH THE DEVICE, IT WAS IDENTIFIED THAT THE AUDIBLE TONE WAS DUE TO A HIGH OUT OF RANGE IMPEDANCE (> 400 OHMS). IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED, AUTO THERAPY TURNED OFF, AND A DEVICE HEADER REVIEW WAS CONDUCTED VIA X-RAY. IT WAS FURTHER REPORTED THAT THERE WERE NO ISSUES IDENTIFIED VIA XRAY OR HEADER REVIEW. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER S-ICD PULSE GENERATOR 4 DAYS AFTER HOSPITALIZATION. NO ISSUES WERE IDENTIFIED WITH THE ELECTRODE. THE ELECTRODE REMAINS IMPLANTED. THERE WERE NO ADVERSE PATENT EFFECTS AS A RESULT OF THE EXPLANT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SQ-RX PULSE GENERATOR SQ-RX PULSE GENERATOR LWS CAMERON HEALTH INC 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| L| R