BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1954214 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24715
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 10, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE WITH NO REMEDIAL ACTION YET TAKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    INFORMATION SUGGESTS THAT THIS DEFIBRILLATION LEAD WAS REMOVED FROM SERVICE, FOR PROBABLE FRACTURE. THIS LEAD HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC. THE TWO ATTEMPTED CRT-DS HAVE NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC EITHER. THE ACUTE RV LEAD WAS UNABLE TO BE SUCCESSFULLY ATTEMPTED FOR IMPLANT PLACED DUE TO SUPERIOR VENA CAVA OCCLUSION. EPICARDIAL PATCHES WERE GOING TO BE PLACED IN LIEU. THE INVESTIGATION IS CONSIDERED CLOSED AT THIS TIME. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED FURTHER INFORMATION INDICATING THAT THE SHOCK IMPEDANCE ON THIS TRANSVENOUS LEAD HAS CONTINUED TO BE HIGHER THAN 125 OHMS. SHORTLY AFTER THE IMPLANT PROCEDURE, THE PHYSICIAN RECOMMENDED DEFIBRILLATION PATCHES TO REDUCE THE SHOCK IMPEDANCE LEVELS, HOWEVER, THE PATIENT DECLINED THE PROCEDURE. THREE MONTHS LATER, NON INVASIVE PROGRAMMED STIMULATION OR DFT TESTING WAS RECOMMENDED BY THE PHYSICIAN, HOWEVER, ONCE AGAIN THE PATIENT DECLINED ADDITIONAL TREATMENT. AS A RESULT, HIGH SHOCK IMPEDANCE LEVELS GREATER THAN 125 OHMS HAS PERSISTED FOR THE PAST YEAR SINCE IMPLANT. IT WAS ALSO NOTED THAT DURING THE IMPLANT PROCEDURE, ONLY ONE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ATTEMPTED FOR IMPLANT, AS THIS DEVICE WAS SUCCESSFULLY IMPLANTED. ADDITIONALLY, THIS DEFIBRILLATION LEAD WAS NOT REMOVED DUE TO PROBABLE FRACTURE, BUT INSTEAD HAS REMAINED IN SERVICE FOR THE PAST YEAR WITH HIGH SHOCK IMPEDANCE LEVELS GREATER THAN 125 OHMS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHANGEOUT, THIS TRANSVENOUS DEFIBRILLATION LEAD IN ASSOCIATION WITH TWO ATTEMPTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) DID EXHIBIT >125 OHMS SHOCK IMPEDANCE IN ALL CONFIGURATIONS. DURING TROUBLESHOOTING THAT ENSUED, UNDER FLOUROSCOPY, A BEND IN THIS RV LEAD WAS OBSERVED. RE-SEATING OF THE DISTAL DF PIN WAS ALSO SUGGESTED AS OART OF TROUBLESHOOTING, HOWEVER THERE WAS NEVER ANY REPORTED EVIDENCE OR ALLEGATION OF A DEVICE TO LEAD CONNECTION ISSUE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 4525| 4469| N118| 0184| H179