BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SBP DR INDUCTIVE PACEMAKER, JPD

    MDR report key: 13969835 · Received March 31, 2022

    Report

    Report Number
    2017865-2022-06822
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    March 15, 2022
    Report Date
    May 23, 2022
    Manufacturer
    ABB
    Product Code
    NVZ
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENTS OF LOSS OF PACING AND FAILURE TO CAPTURE WERE NOT BE CONFIRMED. THE PACER WAS RECEIVED IN NORMAL WORKING CONDITIONS WITH BATTERY VOLTAGE ABOVE ELECTIVE REPLACEMENT INDICATOR (ERI). ELECTRICAL AND MECHANICAL ANALYSIS PERFORMED, INCLUDING CAPTURE TEST UNDER NOMINAL SETTINGS INDICATED NORMAL DEVICE FUNCTIONALITY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE DEVICE PASSED ALL QUALITY CONTROL TESTS PRIOR TO ITS DISTRIBUTION. A LONGEVITY ASSESSMENT WAS PERFORMED AND THE DEVICE WAS IN THE NORMAL RANGE OF OPERATION WITH APPROPRIATE REMAINING LONGEVITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DIZZINESS. DURING FOLLOW-UP, LOSS OF CAPTURE WAS OBSERVED ON THE DEVICE AND RIGHT VENTRICULAR LEAD. DURING REVISION, THE RV LEAD WAS EXPLANTED AND REPLACED WITH A NEW RV LEAD. WHEN CONNECTED TO THE DEVICE, THE NEW RV LEAD ALSO SHOWED LOSS OF CAPTURE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. NO MALFUNCTION WAS ALLEGED AGAINST THE FIRST RV LEAD. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344788 SBP DR INDUCTIVE PACEMAKER, JPD IMPLANTABLE PACEMAKER PULSE GENERATOR NVZ ABB PM2152 P000133881

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention DURATA RV LEAD