| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00041-1 |
| Product Name/Description |
Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators and RestoreUltra and RestoreSensor Implantable Spinal Cord Stimulators
Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators
Model Numbers: 37601, 37602, 37603, 37612
ARTG Numbers: 160118, 188274, 188034, 160117
RestoreUltra and RestoreSensor Implantable Spinal Cord Stimulators
Model Numbers: 37712, 37714
ARTG Numbers: 154866, 177594 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
1) Unexpected Loss of stimulation may occur under the following conditions:
- Switching from a group with two programs to a group with three or four programs where a non-negative contact is shared within the programmed groups.
- Creating Program Groups (Activa SC only) when a second program is created for the first time.
2) Under a specific set of conditions (Activa SC – Models 37602 / 37603 are not affected), typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended:
- Device reaches a power on reset (POR) state. A POR may be detected during interrogation with the patient or physician programmer. The patient will experience loss of therapy if a POR occurs.
- ‘Therapy OFF’ command is sent (by patient programmer, INSR, or ‘THERAPY-STOP’ button on the 8840 clinician programmer) to device while the device is making an automatic periodic battery measurement.
|
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic does not recommend prophylactic explant of devices because these issues can be addressed non-invasively by the clinician using an 8840 clinician programmer or an Implantable Neurostimulator Recharger using the Physician Recharge Mode. The model 8870 software application card used by the programmer is being updated to version BBR01A by Medtronic field representative. Interrogating patient’s device with the updated software version will automatically update the implanted device software and reduce the probability that a loss of stimulation output will occur. To significantly reduce the likelihood of over stimulation or stimulation in the wrong area, patients should avoid over discharge. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-deep-brain-spinal-cord-stimulation-devices-140204.htm . Thia action has been closed-out on 28/01/2016. |
| Contact Information |
02 9857 9000 - Medtronic Australasia |