Sentus ProMRI OTW QP L-85/49 (Biotronik SE & Co. KG) — Injury
An injury event has been reported involving the Sentus ProMRI OTW QP L-85/49 device manufactured by Biotronik SE & Co. KG. The source identifies this as an injury event but does not provide specific clinical details regarding the nature or severity of the patient harm.
The manufacturer (Biotronik SE & Co. KG), clinical teams utilizing implantable MRI-compatible leads, and regulatory/QA professionals responsible for cardiovascular device compliance.
The report of an injury associated with an implantable lead suggests potential performance or safety issues that require monitoring. While the source provides limited detail on the mechanism of injury, such reports typically necessitate internal investigations to determine if the event was device-related, user-related, or a known procedural complication. This may impact the risk-benefit profile documented in the device's technical file.
Review existing risk management files for this specific lead model to ensure injury profiles are within established thresholds. Verify that post-market surveillance systems are capturing and trending similar injury events to determine if additional reporting or corrective actions are necessary. Ensure clinical teams are monitoring patient outcomes for this device class.
Event type: Injury. Device: Sentus ProMRI OTW QP L-85/49 by Biotronik SE & Co. KG.
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