BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT+ DR DUAL-CHAMBER ICD

    MDR report key: 5046840 · Received September 1, 2015

    Report

    Report Number
    2938836-2015-29329
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 29, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CODE AVAILABLE. FINAL ANALYSIS FOUND THE REPORTED FIELD EVENT OF NOISE AND BACKUP DFO WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE NOISE LED TO NUMEROUS HV CHARGES WHICH TRIGGERED THE BACKUP DFO MODE. THE DEVICE WAS TESTED ON THE BENCH AND A SUDDEN DROP IN BATTERY VOLTAGE WAS NOTED. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALY WAS FOUND. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WENT INTO BACKUP VVI MODE AFTER A MULTIPLE NUMBER OF SHOCKS. THE NUMBER OF SHOCKS COULD NOT BE CONFIRMED AS THE DEVICE IMAGE WAS CORRUPTED. THE NUMBER OF SHOCKS MOST LIKELY DEPLETED THE DEVICE BATTERY. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578290 CURRENT+ DR DUAL-CHAMBER ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2211-36 2812544

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention