BEUDAMED
    FDA Recall Open, Classified

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    Recall: Z-1671-2022 · Initiated July 7, 2022

    Recall

    Recall Number
    Z-1671-2022
    Event Number
    90524
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    NIK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 7, 2022
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    Reason

    There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

    Action

    Boston Scientific notified their consignees by letter on 07/07/2022. The Important Programmer Information stated the following: "Programmer Software Information July 2022 - Continued use of older Model 2868 software on Model 3120 ZOOM programmers to support transvenous CRT-Ds and ICDs until supply constraints on newer programmers are resolved. Summary- " Global supply chain challenges have constrained availability of the newer programmers. " Until the supply chain constraints are resolved locally, you may continue using older 3120 ZOOM programmers. " The 2868 software on the 3120 ZOOM programmer has been uninstalled or is outdated. As such, users may observe unexpected behaviors when attempting communications with transvenous defibrillators including the potential inability to interrogate or the display of incorrect/missing parameters " A software update has been developed to resolve some of the disruptive behaviors associated with continued use of 2868 software on the 3120 ZOOM programmer. Boston Scientific will release software after local approval. " The risk of insufficient programmer supply outweighs the risks associated with these unexpected behaviors, therefore, Boston Scientific recommends continued use of 3120 ZOOM programmers for transvenous defibrillators until sufficient supply of the newer programmers can be achieved locally." and provided the following recommendations: "Recommendations: Please distribute this letter to all users of the 3120 ZOOM programmer and complete/return the enclosed Customer Acknowledgment Form. Continue using 3120 ZOOM programmers to interrogate Boston Scientific TV defibrillators, as needed, with the following in mind: 1) If unable to interrogate a TV defibrillator with a 3120 ZOOM programmer, use a 3300 LATITUDE programmer instead. If this behavior occurs, STAT PACE, STAT SHOCK, and DIVERT THERAPY programmer operations4 are not available through a 3120 ZOOM programmer, so external pacing/defibrillation or magnet applicat

    Distribution

    Worldwide Distribution

    Quantity

    17,172 units in total