BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 6705797 · Received July 12, 2017

    Report

    Report Number
    1000165971-2017-00557
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 21, 2017
    Report Date
    June 21, 2017
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIME TO ERI WAS OVER-ESTIMATED. ON (B)(6) 2017 THE BATTERY IMPEDANCE WAS 5.75 KOHMS, THE MAGNET RATE WAS 93 MIN-1 AND THE TIME TO REPLACEMENT WAS DISPLAYED AS 16 MONTHS +/- 1 MONTH. ON (B)(6) 2017, LESS THAN 6 MONTHS LATER, THE TRANSTELEPHONIC MAGNET RATE READING WAS 81.6 MIN-1 INDICATING ERI COULD BE REACHED WITHIN WEEKS. THE RESULTS OF MONTHLY TTM CHECKS ARE AS FOLLOWS: (B)(6) 2017: 91.5 MIN-1, (B)(6) 2017: 91.5 MIN-1, (B)(6) 2017: 89 MIN-1, (B)(6) 2017: 88 MIN-1, (B)(6) 2017: 81.6 MIN-1. THE DEVICE WAS PROGRAMMED IN DDD MODE WITH RATE RESPONSE. A CHANNEL: 75% PACED, 2.5 V/0.5 MS, 453 OHMS AND V CHANNEL: 95% PACED, 2.5 V/0.5 MS, 5.22 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIME TO ERI WAS OVER-ESTIMATED. ON (B)(6) 2017 THE BATTERY IMPEDANCE WAS 5.75 KOHMS, THE MAGNET RATE WAS 93 MIN-1 AND THE TIME TO REPLACEMENT WAS DISPLAYED AS 16 MONTHS +/- 1 MONTH. ON JUNE 21, 2017, LESS THAN 6 MONTHS LATER, THE TRANSTELEPHONIC MAGNET RATE READING WAS 81.6 MIN-1 INDICATING ERI COULD BE REACHED WITHIN WEEKS. THE RESULTS OF MONTHLY TTM CHECKS ARE AS FOLLOWS: (B)(6) 2017: 91.5 MIN-1, (B)(6) 2017: 91.5 MIN-1, (B)(6) 2017: 89 MIN-1, (B)(6) 2017: 88 MIN-1, (B)(6) 2017: 81.6 MIN-1. THE DEVICE WAS PROGRAMMED IN DDD MODE WITH RATE RESPONSE. A CHANNEL: 75% PACED, 2.5V/0.5 MS, 453 OHMS AND V CHANNEL: 95% PACED, 2.5V/0.5 MS, 5.22 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487195 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM RHAPSODY + DR 2530 M040715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention