BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3905731 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12599
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 20, 2013
    Report Date
    July 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED FROM THE FIELD, AND THE HOSPITAL WILL GET BACK WITH FURTHER INFORMATION WHEN THE PATIENT RETURNS TO THE HOSPITAL. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION MADE AVAILABLE FROM THE FIELD INDICATED SURGICAL INTERVENTION TOOK PLACE AND THE COMPETITOR RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO X-RAY WAS PERFORMED BEFOREHAND TO CONFIRM A LEAD DISLODGEMENT. UPON OPENING THE POCKET, THE RA LEAD WAS ALSO FOUND TO BE FRACTURED DUE TO A SUBCLAVIAN CRUSH. WITH A NEW RA LEAD, THE SYSTEM TESTED OUT FINE. THE PATIENT WILL CONTINUE TO BE FOLLOWED-UP. THE PACEMAKER CONTINUES TO REMAIN IMPLANTED AND IN SERVICE WITH THE NEW RA LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT¿S COMPETITOR RIGHT ATRIAL LEAD HAD DISLODGED AND ACCOMPANYING UNDERSENSING, OVERSENSED NOISE, MUSCLE STIMULATION, LOSS OF CAPTURE, AND AN OUT OF RANGE PACING IMPEDANCE MEASUREMENT WHICH TRIGGERED A LEAD SAFETY SWITCH (LSS) OCCURRED. IT IS BELIEVED THE LSS OCCURRED OVER A YEAR AGO AS THE IMPEDANCE MEASUREMENTS WERE NOT OUT OF RANGE DURING THE DEVICE CHECK. SOME UNDERSENSING ON THE RIGHT VENTRICULAR LEAD WAS OBSERVED AS WELL, BUT THE PATIENT HAD A GOOD SINUS RATE AROUND 60 BEATS PER MINUTE. SENSING WAS ADJUSTED IN THE PACEMAKER AND THE PATIENT WAS SENT FOR AN X-RAY, ALTHOUGH THE RESULTS AT THIS TIME ARE NOT AVAILABLE. AT THIS TIME, THE PATIENT¿S SYSTEM CONTINUES TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384123 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R MISMATCH| 1297