Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system's SQ-RX Model 1010 Pulse Generator (PG).
The manufacturer is providing important information about the potential for a shortened replacement interval after a Charge Time (CT) / Battery Depletion (BD) alert has occurred or after the battery status reaches Elective Replacement Indicator (ERI) in the first-generation S-ICD system's SQ-RX Model 1010 PG. This information is not applicable to the EMBLEM MRI or EMBLEM S-ICD.
The manufacturer has observed an elevated rate of these PGs experiencing latent battery malfunctions resulting in accelerated battery depletion and a shortened replacement interval. The affected device is no longer available for implantation, is no longer manufactured, and any remaining inventory is expired.
According to the manufacturer, based on the cumulative survival of 94% at 5 years, the affected device is meeting overall anticipated performance expectations. Approximately 9,000 active PGs remain in service. The projected occurrence rate for latent battery malfunctions for the affected device is up to 2% at 5 years. There have been no reports of injuries or deaths associated with this behavior.
The manufacturer provides the following recommendation:-
- Follow-Up:
- Perform in-clinic checks every 3 months as the PG is not capable of remote patient management;
- If it has been more than 3 months since a patient's last in-clinic follow-up, schedule a follow-up within the next month and every 3 months thereafter;
- During the next follow-up visit, demonstrate the beeper by applying a magnet over the PG to elicit beeping tones; and
- Remind patients to promptly contact their physician if beeping tones are heard from their PG as this may be an indication of a CT / BD alert or ERI.
- Append the patient's medical record with this information to maintain awareness of this topic for the remaining service life of their PG
- Evaluate Risk: The potential for life-threatening harm is greater for patients who have experienced life-threatening ventricular arrhythmias, patients not followed every 3 months, and/or patients who are unable to hear beeping tones. For these patients, the benefit associated with prophylactically replacing the PG may outweigh the risks associated with a shortened replacement interval due to latent battery malfunction.
- CT / BD Alerts: Promptly investigate any beeping tones, CT alerts, or BD alerts and report them to the manufacturer's Technical Services. Using saved PG data, Technical Services can determine if an accelerated battery depletion exists and provide guidance for replacement.
- ERI: To mitigate the rare potential for undetected accelerated battery depletion, replace SQ-RX Model 1010 PGs within 20 days of ERI. If a longer replacement interval is desired, save PG data and contact the Technical Service to determine a recommended replacement interval. [Note: CT / BD Alerts appearing before or after ERI should always be reported to Technical Services for evaluation.]
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 November 2018