Incorrect dates are displayed on certain pacemaker models using the Model 3120 Zoom (TM) programmer following January 10, 2024.

ANZCDACC management recommendations for Boston Scientific Zoom programmer alert (December 2023)

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Device:

Boston Scientific Model 3120 ZoomTM Programmer running software Model 2892

TGA Reference:  RC-2023-RN-01030-1

Australian Register of Therapeutic Goods (ARTG):  123599

Medsafe Notification Reference:  32214

Advisory grade TGA:  Class II

Committee Members:
Paul Gould (Chair), Rajesh Subbiah, Paul Weatherley, Nigel Lever, Jason Davies, Susan Sinclair, Justin Phan

Description:

The Model 2892 software application determines date information using the Model 3120 ZOOM programmer’s clock. Based on the design of the Model 2892 software application, the clock parameter supports dates from 1 January 1990 until 10 January 2024. After this date, the clock parameter will restart and incorrectly display certain diagnostic dates on the programmer screen, save-to-disk, and in printed reports.The Model 2892 software application supports the remaining Boston Scientific ALTRUATM, INSIGNIATM and pacemakers distributed between October 2001 and August 2018. Beginning 10 January 2024, the Model 2892 software on Model 3120 ZoomTM programmers will display diagnostic dates incorrectly, with a year in the 1990s.

Clinical Impact:

  • Affected diagnostic dates that will display incorrectly on or after 10 January 2024, include date of last battery test, last programmed date, last interrogation date, last reset counter / histograms, and dates of follow-up tests such as intrinsic amplitude, pacing impedance, and pacing threshold tests
  • Replacement indicator dates and dates of events in the arrhythmia logbook are not affected and display correctly
  • There is no impact to the performance of the pacemaker, actual longevity remaining nor battery gas gause display

NB: The Model 3300 LATITUDETM programmer is not affected.

Recommendation:

  • Prophylactic replacement of pacemakers due to incorrect dates is not recommended.
  • Where possible, interrogate an ALTRUATM or INSIGNIATM pacemaker with a Model 3300 LATITUDETM programmer
  • An approximate date (within a two-day range) can be determined using a table provided by the manufacturer (copy provided below).

The ANZCDACC encourage you to report any adverse event or near (potential) adverse event associated with the use of a medical device including any abnormal CIED or lead function.

We encourage reporting to ANZCDACC directly via the Committee chair Dr Paul Gould [email protected] and to the following regulators.

In Australia, report to the TGA:
Online: https://www.tga.gov.au/reporting-problems

In New Zealand, report to Medsafe:
Post: Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6145
Email: [email protected]