Published: 4 February 2019
Safety Information
Alert Communication
Recall and Hazard Alert: Medtronic Adapta Dual Chamber Pacemaker
4 February 2019
Products Affected
Information for consumers and caregivers
Information for healthcare professionals
How to report adverse effects
Medtronic New Zealand Ltd is informing cardiologists with affected patients, of an Urgent Medical Device Recall and Hazard Alert affecting a subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta. Please note that not all devices within this brand name are affected by this recall.
These devices provide bradycardia pacing therapy for patients with bradyarrhythmias.
The Medtronic statement on this matter can be viewed at: www.medtronic.com/us-en/healthcare-professionals/products/product-performance/dual-chamber-pacemaker-recall.html
Cardiologists who have affected patients have been contacted by way of an Urgent Medical Device Recall and Hazard Alert letter. Medtronic has further information relating to the recall and hazard alert on its website: www.medtronic.com/us-en/healthcare-professionals/products/product-performance/dual-chamber-pacemaker-recall.html
Additionally, patients and cardiologists may determine if a specific device is affected by looking up the serial number of their device on Medtronic’s Product Performance website: www.medtronic.com/productperformance/
Products Affected
The product is: Medtronic Adapta dual chamber pacemaker
Information for consumers and caregivers
- If you have a pacemaker which is affected by this issue, you should be contacted by your cardiologist.
- If you have a pacemaker which is affected by this issue, your cardiologist has been provided with recommendations with regard to any action which may be required.
- If you have any concerns about your pacemaker, contact your cardiologist in the first instance.
Information for healthcare professionals
- An Urgent Medical Device Recall and Hazard Alert has been implemented to communicate the issue to all consignees (accounts and cardiologists) who have received affected product or who are following impacted patients according to MDT records.
- Identified implanting and follow-up cardiologists have been sent the recall and hazard alert PHYSICIAN Letter and be asked to follow the instructions within, including patient management recommendations.
- Cardiologists will receive a physician-specific list of patients for whom Medtronic records show they are either listed as the patient’s implanting or follow-up physician.
- Patients requiring intervention should be contacted as soon as possible.
- Patient risk is determined by the patient’s underlying cardiac rhythm and whether the device is in a susceptible pacing mode.
- For any questions you may have regarding this communication, please contact 0800 377 807.
How to report adverse events
| devices@health.govt.nz | |
| Online | Adverse Event Report (Consumers) (Microsoft Word document 85 KB, 3 pages) |
| Post | Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6415 |
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