BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3231137 · Received July 11, 2013

    Report

    Report Number
    3231137
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD IMPLANTATION OF PACEMAKER. THE PATIENT SENT DEVICE FOLLOW-UP REPORT,VIA REMOTE MONITORING SYSTEM APPROXIMATELY 26 DAYS LATER, AS INSTRUCTED. RECEIVING DEVICE CLINIC NURSE NOTED "APPROXIMATE TIME TO EXPLANT" TO BE TOO SOON FOR DEVICE THAT WAS JUST IMPLANTED. SHE SPOKE WITH MANUFACTURER REPRESENTATIVE, WHO CONFIRMED THAT THERE WAS A PROBLEM WITH THE DEVICE. "HE EVALUATED THE REPORT IN PERSON THE NEXT DAY, AND CONFERRED WITH TECHNICAL SERVICE, WHO SUGGESTED THAT THE PATIENT BE BROUGHT IN, SO THAT INFORMATION ON PPM COULD BE SAVED TO A FLASH DRIVE." THE PATIENT PRESENTED TO THE DEVICE CLINIC THE FOLLOWING DAY TO EVALUATE BATTERY STATUS. "BATTERY STATUS SHOWED REMAINING LONGEVITY OF BATTERY AT ONE YEAR." THE NURSE NOTIFIED THE IMPLANTING PHYSICIAN OF THE FINDING. AFTER THE PATIENT VISIT TO THE DEVICE CLINIC, THE PHYSICIAN RECEIVED A FOLLOW-UP FROM BOSTON SCIENTIFIC ENGINEERS RECOMMENDING THAT THE GENERATOR BE REPLACED AS SOON AS POSSIBLE. THE PATIENT PRESENTED TO THE OFFICE THE FOLLOWING DAY. IT WAS EXPLAINED TO THE PATIENT, THAT THE PPM MUST BE REPLACED, SINCE IT CANNOT BE EXPECTED TO FUNCTION RELIABLY. THE PATIENT WAS ADMITTED TO THE HOSPITAL, DIRECTLY FROM THE OFFICE. THE PROCEDURE WAS PERFORMED THAT EVENING. THE WAS KEPT OVERNIGHT FOR OBSERVATION.======================MANUFACTURER RESPONSE FOR PACEMAKER, INGENIO (PER SITE REPORTER).======================TWO DAYS AFTER THE DEVICE INTERROGATION IN THE DEVICE CLINIC, THE PHYSICIAN RECEIVED "FOLLOW-UP FROM BOSTON SCIENTIFIC ENGINEERS THIS AFTERNOON, INFORMING ME THAT PACEMAKER BATTERY HAS DEPLETED ABRUPTLY AND ABNORMALLY." AS PER PHYSICIAN, "THE BATTERY WILL PROBABLY REACH ERI BY TOMORROW, AND EOL VERY SOON AFTER. BOSTON SCIENTIFIC RECOMMENDS THE GENERATOR BE REPLACED AS SOON AS POSSIBLE." WE ARE AWAITING FORMAL RESPONSE AFTER THEY HAVE THOROUGHLY EXAMINED THE DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EXPLANTATION OF OLD PACEMAKER AND IMPLANTATION OF NEW PACEMAKER.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319854 INGENIO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) NVZ BOSTON SCIENTIFIC CORPORATION K173 DR *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR