| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2019-RN-00080-1 |
| Product Name/Description |
Adapta Dual Chamber Pacemakers
Model Numbers:
ADDR01 - ARTG 125076
ADDR03 - ARTG 125077
ADDR06 - ARTG 125078
ADDRL1 - ARTG 125084
ADDRS1 - ARTG 125085
ADVDD01 - ARTG 125080 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/01/2019 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic advises this subset of Medtronic dual chamber pacemakers has the potential to experience a circuit error during a unique sequence of events when programmed to a dual chamber mode with atrial sensing which may cause a pause in pacing therapy.
Medtronic estimates that on average, a device in a susceptible pacing mode has a 2.8% chance per month of experiencing a pacing pause of 1.5 seconds or longer. Risk is minimised in patients who have an escape rhythm adequate to prevent syncope during a loss of ventricular pacing, since a ventricular-sensed event (VS) restores full device functionality. No risk of a pause due to this circuit error exists for patients programmed to a non-susceptible pacing mode.
Through 4 January 2019, Medtronic is aware of four (4) reported occurrences in two (2) patients where a pause in pacing therapy was clinically apparent due to this circuit error. No deaths have been reported as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is developing a software update that can be installed into affected devices to correct this issue. Medtronic estimates submission of this software update to regulatory agencies by the second half of 2019. Upon subsequent regulatory approval, Medtronic will notify customers of its availability. Until that time, Medtronic is providing the patient management recommendations described in the customer and physician letters.
UPDATE 23/09/2019:
A follow up (phase II) action focuses on communicating to impacted consignees two SW updates that will be installed on all impacted Carelink 2090 and Carelink Encore programmers to address this issue. The first software update is a routine cybersecurity update, and the second addresses this issue. Medtronic field staff will deliver the notifications and install the 2 software updates available on 2 USBs.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0427 450 494 - Michael Keenan - Medtronic |