Medtronic Adapta Pacing System (Adapta, Sensia, Attesta) (2019-01-14)

Starting date:

January 14, 2019

Posting date:

January 30, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68958

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  Reason
• 
  Affected products

Affected Products

1. Adapta
2. Sensia
3. Attesta

Reason

Devices in the affected subset, when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality. For this error to occur, a unique combination of events must take place while the device is processing an atrial-sensed event. If this error occurs, the device will be unable to provide pacing until a ventricular-sensed event (VS) is detected. Once a VS is detected, normal pacing functionality is restored immediately. If a VS is not detected, the device will withhold both atrial and ventricular pacing. In addition, until a VS is detected, the device will be unable to initiate a session with a programmer, initiate a session with a CareLink Remote Monitor, or respond to a magnet. Single chamber and dual chamber pacing modes that do not sense atrial activity are not susceptible to this circuit error.

Affected products