BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3863796 · Received June 10, 2014

    Report

    Report Number
    1000165971-2014-00335
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2014, DURING A REGULAR FOLLOW-UP, THE PACEMAKER REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND BATTERY IMPEDANCE WAS AT 10KOHMS. ACCORDING TO THE PATIENT, THE PATIENT FELT SOME DISCOMFORT. AT THE PREVIOUS FOLLOW-UP, PERFORMED ON (B)(6) 2013 BATTERY IMPEDANCE WAS AT 1.53KOHMS. A REINTERVENTION WAS PERFORMED ON (B)(6) 2014 AND THE DEVICE WAS REPLACED. PHYSICIAN¿S COMMENT: VENTRICULAR OUTPUT WAS SET TO 3V/1MS ON THIS EXTRACTED PACEMAKER, BUT MODE WAS SAFER WITH LOW PACING %. CONSIDERING THESE CONDITIONS, IT COULD BE TOO EARLY TO REACH RRT. IN 5 YEARS AND 7 MONTHS THUS THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2014, DURING A REGULAR FOLLOW-UP, THE PACEMAKER REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND BATTERY IMPEDANCE WAS AT 10KOHMS. ACCORDING TO THE PATIENT, THE PATIENT FELT SOME DISCOMFORT. AT THE PREVIOUS FOLLOW-UP, PERFORMED ON (B)(6) 2013 BATTERY IMPEDANCE WAS AT 1.53KOHMS. A REINTERVENTION WAS PERFORMED ON (B)(6) 2014 AND THE DEVICE WAS REPLACED. PHYSICIAN'S COMMENT: VENTRICULAR OUTPUT WAS SET TO 3V/1MS ON THIS EXTRACTED PACEMAKER, BUT MODE WAS SAFER WITH LOW PACING PERCENTAGE. CONSIDERING THESE CONDITIONS, IT COULD BE TOO EARLY TO REACH RRT. IN 5 YEARS AND 7 MONTHS THUS THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341160 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention