BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3992365 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14850
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE MET 43% OF EXPECTED LONGEVITY BASED ON THE SET OF PROGRAMMED VALUES AND USE CONDITIONS NOTED UPON DEVICE RECEIPT. THE BATTERY TREND CURVE BASED ON PERFORMANCE DATA INDICATED RAPID BATTERY DEPLETION. ANALYSIS OF THE CIRCUITRY WAS TERMINATED SINCE NO BATTERY DEPLETION MECHANISM, SUCH AS HIGH SYSTEM CURRENT DRAIN, WAS OBSERVED. ANALYSIS OF THE BATTERY CELL WAS THEN PERFORMED. THE ANODE TAB, FEEDTHROUGH PIN, AND CATHODE TABS WERE CUT SO THE COILED ELECTRODE ASSEMBLY (HEREAFTER, ¿COIL¿) COULD BE REMOVED FROM THE INSULATOR CUP AND EXAMINED FOR SIGNS OF INTERNAL SHORTING. A VISUAL EXAMINATION OF THE TOP COIL EDGE INDICATED THE COIL WAS WOUND CORRECTLY AND THERE WERE NO OPENINGS IN THE TOP OR BOTTOM SEPARATOR EDGES. THE COIL WAS UNWOUND AND THERE WAS A DISCOLORED AREA FOUND ON THE ANODE AND CATHODE SEPARATORS IN SEGMENT 2 OF THE COIL, ABOUT 1/3 OF THE WAY UP FROM THE BOTTOM EDGE. CLOSER EXAMINATION OF THIS AREA REVEALED THERE WERE MELTED HOLES AT EACH LOCATION. THE SEGMENTS OF SEPARATOR FROM EACH LOCATION WERE REMOVED, WITH THE MATERIAL AROUND THE MELT AREAS SENT FOR ANALYSIS. IT WAS DETERMINED THAT THE MATERIAL CONTAINED SILVER AND VA NADIUM, WHICH ARE CONSTITUENTS OF THE CATHODE MATERIAL. EXAMINATION OF THE CATHODE SURFACE BELOW THE SEPARATOR HOLE SHOWED A CATHODE PARTICLE PROTRUDING FROM THE SURFACE, IN THE DIRECTION OF THE ANODE. BASED ON THE DESTRUCTIVE ANALYSIS RESULTS, THE BATTERY INTERNALLY SHORTED FROM A CATHODE PARTICLE PUNCTURING THE CATHODE AND ANODE SEPARATORS AND SUBSEQUENTLY TOUCHING THE ADJACENT ANODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS EARLY BATTERY DEPLETION AND THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472304 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 693565 LEAD