BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 11104227 · Received January 2, 2021

    Report

    Report Number
    2124215-2020-25178
    Event Type
    Injury
    Date Received
    January 2, 2021
    Date of Event
    October 15, 2020
    Report Date
    March 10, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WOULD BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED FROM THE ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. LONGEVITY CALCULATIONS WERE PERFORMED AND AN INCREASED RATE OF POWER CONSUMPTION WAS CONFIRMED. ANALYSIS CONFIRMED THIS DEVICE APPEARED TO BE EXHIBITING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION ASSOCIATED WITH THE PACEMAKER'S LOW VOLTAGE CAPACITORS. THIS HIGH CURRENT CONDITION DEPLETED THE DEVICE'S BATTERY FASTER THAN NORMAL.

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WOULD BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED FROM THE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE PULSE GENERATOR (PACEMAKER) EXHIBITED PREMATURE BATTERY DEPLETION (PBD) BEHAVIOR. THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. EVENTUALLY, THIS DEVICE WAS EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE PULSE GENERATOR (PACEMAKER) EXHIBITED PREMATURE BATTERY DEPLETION (PBD) BEHAVIOR. THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. EVENTUALLY, THIS DEVICE WAS EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE EXHIBITED PREMATURE BATTERY DEPLETION (PBD) BEHAVIOR. THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437 INGENIO IMPLANTABLE PULSE GENERATOR (PACEMAKER) LWW BOSTON SCIENTIFIC CORPORATION J172 109895

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R