BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3231963 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11232
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LEAD IMPEDANCES GREATER THAN 2000 OHMS, LOSS OF CAPTURE, UNDERSENSING. THERE WERE NO ADVERSE PATIENT EFFECTS AS IT WAS NOTED THE PATIENT DID NOT VENTRICULAR PACE. A LEAD FRACTURE WAS NOT ABLE TO BE IDENTIFIED ON X-RAY/FLUOROSCOPY EVALUATION. HOWEVER, DUE TO THE PRODUCT ISSUE, SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE PACEMAKER GENERATOR REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330791 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4137| S603| 4470| 4469