WaveWriter Alpha™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) – Effects associated with device resets

A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific Pte Ltd to inform healthcare professionals of the potential for WaveWriter Alpha™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) stimulation therapy to be transiently suspended during charging due to a device reset, which occurs in response to the presence of potential interference during IPG charging. The frequency of occurrence of this IPG reset behaviour is random and remote, and patients with devices exhibiting this reset behaviour may not report any discernible impact. However, Boston Scientific has received a limited number of patient reports of undesired sensation and / or awareness of IPG turning on and off during IPG charging. An IPG firmware update is available to prevent this reset behaviour from occurring during charging. Healthcare professionals are advised to review any patient reports of undesired sensations indicative of potential device reset behaviour during IPG charging and report these observations to Boston Scientific. After verification, an in-field IPG firmware update will be scheduled for the patient’s device to eliminate the possibility of a potential system reset. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.