BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATCH

    MDR report key: 2041437 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01001
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 6, 2010
    Report Date
    November 23, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT ADDITIONAL OUT OF RANGE MEASUREMENTS WERE SEEN. NO INTERVENTION WAS PERFORMED. THE SYSTEM WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCES AT IMPLANT. A 1.1 JOULE SHOCK WAS DELIVERED WHICH RETURNED THE SHOCK IMPEDANCE TO A NORMAL VALUE. SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE (FR) INDICATED THAT THE SHOCK IMPEDANCE ROSE TO AN OUT OF RANGE VALUE AGAIN. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATCH IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0067

    Patients

    Seq Age Sex Outcome Treatment
    1 199 MO Hospitalization| L| R 4046| 1860| MISMATCH| 1790| E102