BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM RF

    MDR report key: 8744250 · Received June 28, 2019

    Report

    Report Number
    1000165971-2019-00385
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 6, 2019
    Report Date
    March 18, 2020
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    P060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Additional Manufacturer Narrative · 0

    H6 (CONCLUSION CODE) UPDATED. ADDITIONAL ANALYSIS WAS PERFORMED. THE REPORTED BEHAVIOR WAS A CONSEQUENCE OF THE DELIVERY OF SHOCKS IN OVERLOAD CONDITIONS ON AN ABRADED DEFIBRILLATION LEAD. PLEASE REFER TO THE UPDATED ANALYSIS REPORT.

    Description of Event or Problem · 0

    THE DEFIBRILLATION SYSTEM WAS IMPLANTED ON (B)(6)2014 . REPORTEDLY, ON (B)(6)2019 , THE PATIENT RECEIVED A SHOCK THERAPY WHILST HANGING HEAVY TAPESTRY ON A WALL. UPON DEVICE INTERROGATION ON(B)(6)2019 , MANY WARNING MESSAGES WERE DISPLAYED, INCLUDING MESSAGES STATING THAT THE DEVICE HAD BEEN REINITIALIZED NINE TIMES SINCE THE BEGINNING OF LIFE AND THAT A RESET OCCURRED ON (B)(6)2019 . A MESSAGE INDICATING THAT THE DEVICE HAD BEEN RESET TO NOMINAL VALUES FOLLOWING RE-INITIALIZATION WAS ALSO OBSERVED. LIMITED DIAGNOSTIC INFORMATION WAS AVAILABLE DURING THE INTERROGATION. FOLLOWING THE RECOMMENDATIONS PROVIDED ON (B)(6)2019 , THE ICD WAS EXPLANTED ON(B)(6)2019 AND SHOULD BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    THE DEFIBRILLATION SYSTEM WAS IMPLANTED ON (B)(6) 2014. REPORTEDLY, ON (B)(6) 2019, THE PATIENT RECEIVED A SHOCK THERAPY WHILST HANGING HEAVY TAPESTRY ON A WALL. UPON DEVICE INTERROGATION ON (B)(6) 2019, MANY WARNING MESSAGES WERE DISPLAYED, INCLUDING MESSAGES STATING THAT THE DEVICE HAD BEEN REINITIALIZED NINE TIMES SINCE THE BEGINNING OF LIFE AND THAT A RESET OCCURRED ON (B)(6) 2019. A MESSAGE INDICATING THAT THE DEVICE HAD BEEN RESET TO NOMINAL VALUES FOLLOWING RE-INITIALIZATION WAS ALSO OBSERVED. LIMITED DIAGNOSTIC INFORMATION WAS AVAILABLE DURING THE INTERROGATION. FOLLOWING THE RECOMMENDATIONS PROVIDED ON (B)(6) 2019, THE ICD WAS EXPLANTED ON (B)(6) 2019 AND SHOULD BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE DEFIBRILLATION SYSTEM WAS IMPLANTED ON (B)(6) 2014. REPORTEDLY, ON (B)(6) 2019, THE PATIENT RECEIVED A SHOCK THERAPY WHILST HANGING HEAVY TAPESTRY ON A WALL. UPON DEVICE INTERROGATION ON (B)(6) 2019, MANY WARNING MESSAGES WERE DISPLAYED, INCLUDING MESSAGES STATING THAT THE DEVICE HAD BEEN REINITIALIZED NINE TIMES SINCE THE BEGINNING OF LIFE AND THAT A RESET OCCURRED ON (B)(6) 2019. A MESSAGE INDICATING THAT THE DEVICE HAD BEEN RESET TO NOMINAL VALUES FOLLOWING RE-INITIALIZATION WAS ALSO OBSERVED. LIMITED DIAGNOSTIC INFORMATION WAS AVAILABLE DURING THE INTERROGATION. FOLLOWING THE RECOMMENDATIONS PROVIDED ON (B)(6) 2019, THE ICD WAS EXPLANTED ON (B)(6) 2019 AND SHOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538206 PARADYM RF DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF DR 9550 2789

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention