OECDReference EN/AU/PS1097612
Wireless Recharger Model WR9220 and WR9200 for Rechargeable Implanted Neurostimulator
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- Wireless Recharger Model WR9220 and WR9200 for Rechargeable Implanted Neurostimulator
Official information
Risk and measures
- Risk or hazard
- 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. 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.
- Recommendations
- 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
Official information
Economic operators
- Manufacturer
- Medtronic Pty Ltd
Territory
Geography
- Origin
- United States
- Distribution
- Retirada en Australia
- Country of recall
- Australia
Provenance and context
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