BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3951051 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-13456
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    December 3, 2013
    Report Date
    January 29, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF THE DEVICE MEMORY REVEALED THAT THE DEVICE HAD DELIVERED A 31 JOULE SHOCK INTO A SHORTED OUTPUT CONDITION. THEN A .1 JOULE SHOCK WAS PERFORMED INTO AN OPEN LEAD CONDITION IN BOTH INITIAL AND REVERSED POLARITIES WHICH RETURNED IMPEDANCES GREATER THAN 125 OHMS AND LESS THAN 20 OHMS. THIS CONFIRMED THAT THE DEVICE'S OUTPUT BRIDGE HAD SUSTAINED INDUCED HIGH ENERGY OVERSTRESS DAMAGE AS A RESULT OF SHOCKING INTO A SHORTED LEAD CONDITION RESULTING IN NO THERAPY AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING ROUTINE PATIENT FOLLOW-UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT-OF-RANGE SHOCKING LEAD IMPEDANCE (SLI) MEASUREMENT OF LESS THAN 20 OHMS. LIKEWISE, THERE WAS AN INCREASED PACING THRESHOLD MEASUREMENT FROM 1.0 VOLT AT 0.5 MS TO 2.0 VOLTS AT 0.5 MS. ALL OTHER ELECTRICAL PARAMETERS WERE IN WITHIN NORMAL LEVELS. ON REVIEW, THE PATIENT WAS NOT PACEMAKER DEPENDENT. DISK ANALYSIS WAS PERFORMED WHICH REVEALED A SUDDEN DROP IN SLI HOWEVER ALL PREVIOUS MEASUREMENTS AVAILABLE IN THE TREND SHOWED STABLE SLI AROUND 33 TO 37 OHMS. LIKEWISE, STORED ELECTROGRAMS WERE REVIEWED AND ALL CHANNELS WERE CLEAN. ADDITIONAL INFORMATION INDICATED THAT A SYNCHRONOUS SHOCK WAS DELIVERED WHICH PRODUCED A SHOCK IMPEDANCE OF LESS THAN 20 OHMS AND A SHORTED LEAD CONDITION WAS FOUND. ADDITIONALLY, A SMALL INSULATION ISSUE WAS VISIBLE AROUND THE CLAVICLE AREA WHICH WAS CONFIRMED THROUGH FLUOROSCOPY. LOW, OUT-OF-RANGE PACING IMPEDANCES WERE ALSO OBSERVED. THIS LEAD WAS SURGICALLY ABANDONED IN THE PATIENT AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED WITH GOOD ELECTRICAL PARAMETERS. THE DEVICE WAS ALSO EXPLANTED AND REPLACED WITH A NEW ICD. AN INDUCTION TEST WAS THEN PERFORMED WITH 21 JOULES OF SHOCK WHICH EFFECTIVELY CONVERTED VENTRICULAR FIBRILLATION (VF). THE DEVICE IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427630 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R T177| 0175