BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 3822715 · Received May 21, 2014

    Report

    Report Number
    1000165971-2014-00290
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    REPORTEDLY, DURING A SCHEDULED FOLLOW-UP PERFORMED ON (B)(6) 2014, THE PHYSICIAN DETECTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME. THE DEVICE HAS BEEN REPLACED ON (B)(6) 2014. SINCE THE DEVICE DID NEARLY NOT PACE AND ONLY ONE SHOCK HAS BEEN APPLIED BY THE DEVICE, THE REACHED LONGEVITY IS SUSPECTED TO BE MUCH TOO SHORT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A SCHEDULED FOLLOW-UP PERFORMED ON (B)(6) 2014, THE PHYSICIAN DETECTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME. THE DEVICE HAS BEEN REPLACED ON (B)(6) 2014. SINCE THE DEVICE DID NEARLY NOT PACE AND ONLY ONE SHOCK HAS BEEN APPLIED BY THE DEVICE, THE REACHED LONGEVITY IS SUSPECTED TO BE MUCH TOO SHORT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303543 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM DR 8550 2404

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention