BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2050251 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04081
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES WERE REMOVED FROM SERVICE FOR REASON OF PATIENT INFECTION. NO FURTHER INFORMATION IS EXPECTED AT THIS TIME. IF NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN THE PATIENT'S DEVICE SYSTEM DELIVERED INAPPROPRIATE SHOCK THERAPY. THE PHYSICIAN ALSO STATED THAT THE PATIENT WAS ADMINISTERED ANTIBIOTICS FOR A POTENTIAL BLOOD INFECTION. THE PHYSICIAN THOUGHT THIS MAY STEM FROM THE DEVICE ITSELF. THE PATIENT HAD ADMITTED TO THE EMERGENCY ROOM, WITH FEVER, AND REPORTED BEING SHOCKED. THE DEVICE LOGBOOK SHOWED ONE EVENT THAT WAS NOT OVERWRITTEN, THAT APPEARED TO BE SINUS TACHYCARDIA THAT WENT ABOVE 150 BEATS PER MINUTE. THE PATIENT DID RECEIVE 6 ATP BURSTS X 10, THEN HIT ATP TIMEOUT AND GOT A 2 JOULES SHOCK AND STILL KEPT GOING, THEN ADMINISTERED A 5 JOULES SHOCK, THEN 41 JOULES WHICH CHANGED THE SYMPTOM TO A V GREATER THAN A CRITERIA AND SLOWED TO A SINUS TACHYCARDIA AT WHICH TIME HE RECEIVED A SECOND 41 JOULES SHOCK WITH V GREATER THAN A CRITERIA FOR 10 BEATS AND THEN SINUS TACHYCARDIA ONCE AGAIN. THAT DAY AND THE FOLLOWING DAY, THE PATIENT RECEIVED MULTIPLE ATP THERAPY. THE LOCAL AREA SALES REPRESENTATIVE EXPLAINED THE CRITERIA FOR THE ATP AND SHOCK, BUT THE PHYSICIAN STILL THOUGHT IT WAS INAPPROPRIATE SHOCK. SINCE THEN, THERE HAS BEEN NO FURTHER EPISODE OR DELIVERY OF THERAPY. THE PATIENT IS IN THE HOSPITAL RECEIVING A PHARMACEUTICAL INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 0185| E110