BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 6905272 · Received September 29, 2017

    Report

    Report Number
    1000165971-2017-00728
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    August 31, 2017
    Report Date
    September 1, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2017, EARLY BATTERY DEPLETION WAS REPORTED FOR THE SUBJECT DEVICE. THE BATTERY VOLTAGE AND MAGNET RATE HAD DECREASED FROM 2.92V AND 87 MIN-1 ON (B)(6) 2017 TO 2.68V AND 82 MIN-1 ON (B)(6) 2017. THE FOLLOWING WARNING MESSAGES WERE DISPLAYED: '[27] THE DEVICE WAS REINITIALIZED 2 TIMES SINCE THE BEGINNING OF LIFE. LAST RESET DATE: (B)(6) 2017 4:41, [18] R.R.T (RECOMMENDED REPLACEMENT TIME) DETECTED: PLAN TO REPLACE DEVICE." THE BATTERY CURVE WAS REPORTEDLY SHOWING THAT THE BATTERY VOLTAGE ONCE REACHED THE END OF SERVICE LEVEL. BATTERY REFORMING WAS PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT DID NOT UNDERGO TO ANY EXAMINATIONS SUCH AS MRI SINCE THE LAST FOLLOW-UP. THE DEVICE WILL BE REPLACED ON (B)(6) 2017. PRELIMINARY ANALYSIS CONFIRMED THAT THE ICD REACHED ITS RRT POINT. PATIENT CARE RECOMMENDATIONS WERE PROVIDED ACCORDINGLY TO REPLACE THE ICD. IT WAS ALSO CONFIRMED THAT TWO RESETS OCCURRED ON 15 AUG 2017 AND TOTAL CHARGE TIME SINCE IMPLANTATION WAS AROUND 3 MINUTES. THE DEVICE WAS EXPLANTED ON 08 SEPTEMBER 2017 AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2017, EARLY BATTERY DEPLETION WAS REPORTED FOR THE SUBJECT DEVICE. THE BATTERY VOLTAGE AND MAGNET RATE HAD DECREASED FROM 2.92V AND 87 MIN-1 ON (B)(6) 2017 TO 2.68V AND 82 MIN-1 ON (B)(6) 2017. THE FOLLOWING WARNING MESSAGES WERE DISPLAYED: "[27] THE DEVICE WAS REINITIALIZED 2 TIMES SINCE THE BEGINNING OF LIFE. LAST RESET DATE: (B)(6) 2017 4:41 [18] R.R.T (RECOMMENDED REPLACEMENT TIME) DETECTED: PLAN TO REPLACE DEVICE." THE BATTERY CURVE WAS REPORTEDLY SHOWING THAT THE BATTERY VOLTAGE ONCE REACHED THE END OF SERVICE LEVEL. BATTERY REFORMING WAS PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT DID NOT UNDERGO TO ANY EXAMINATIONS SUCH AS MRI SINCE THE LAST FOLLOW-UP. THE DEVICE WILL BE REPLACED ON (B)(6) 2017. PRELIMINARY ANALYSIS CONFIRMED THAT THE ICD REACHED ITS RRT POINT.PATIENT CARE RECOMMENDATIONS WERE PROVIDED ACCORDINGLY TO REPLACE THE ICD. IT WAS ALSO CONFIRMED THAT TWO RESETS OCCURRED ON (B)(6) 2017 AND TOTAL CHARGE TIME SINCE IMPLANTATION WAS AROUND 3MINUTES. THE DEVICE WAS EXPLANTED ON (B)(6) 2017 AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685102 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM DR 8550 2549

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention