PRA number
Published date
Product description
Wireless Recharger Model WR9220 and WR9200
RECHARGER KITs InterStim Micro, ACTIVA RC and RestoreUltra & RestoreSensor
Product numbers: RS5200, RS6200 and RS7200
ARTGs 121279, 355990 and 366470
The Wireless Recharger (WR9220 and WR9200) is used to recharge the battery of a rechargeable implanted neurostimulator. Rechargers are provided as part of a kit that includes the recharger, dock, USB charging cable, AC power adapter, and drape or belt.
Reasons the product is recalled
The Medtronic WR9220 and WR9200 Rechargers may become unresponsive when:
- the product is fully depleted; and
- placed on the dock; and
- quickly removed within 20 seconds, interrupting the initialisation routine.
When the Wireless Recharger becomes unresponsive, the Wireless Recharger:
- will not respond to a button press
- cannot pair with the recharger app
- the recharger battery indicator will flash continuously when placed on the battery dock.
The hazards to consumers
In the event of an unresponsive Wireless Recharger, the user will not be able to charge their implanted neurostimulator until a replacement Wireless Recharger device is received.
This may lead to loss of therapy and the return of symptoms.
What consumers should do
Consumers can prevent this issue from occurring by:
- Following the instructions in the Micro Therapy Guide(PH)/Patient User Guides (DBS, SCS) by placing the Wireless Recharger on the dock and charging the device to full charge before first use.
- Leaving the Recharger on the charging dock, that is connected to power, to maintain full charge between recharging sessions.
Medtronic will contact affected users in writing to advise them of the issue.
How do users get a replacement for an unresponsive recharger?
- If the wireless recharger becomes unresponsive or if users have any additional questions, they should contact Medtronic Patient Services at 1800 652 972 (Monday to Friday, 8am – 5pm AEST) or email rs.sydaustralianeurosupport@medtronic.com.
- Users should complete and return the confirmation form enclosed with Medtronic’s letter, acknowledging they have received this information
Supplier
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.