BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 8468467 · Received April 1, 2019

    Report

    Report Number
    3004209178-2019-06355
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    February 8, 2019
    Report Date
    May 9, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00613994713650
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 429688 LEAD, IMPLANT DATE: (B)(6) 2015; 638RL28 HEART RING, IMPLANT DATE: (B)(6) 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 93.6% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS EARLY BATTERY DEPLETION OF A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG). IT WAS NOTED THE IPG HAD BEEN USED AS A BI VENTRICULAR PACEMAKER. THE DEVICE WAS REMOVED AND REPLACED WITH A BI VENTRICULAR PACEMAKER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262972 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. A2DR01 00613994713650

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 4136 LEAD