COBALT¿ XT DR MRI SURESCAN¿ (MEDTRONIC EUROPE SARL) — Injury
An injury event was reported involving the Cobalt XT DR MRI SureScan device manufactured by Medtronic Europe SARL.
This affects Medtronic Europe SARL, healthcare providers utilizing MRI-compatible implantable pulse generators, and personnel responsible for device safety monitoring and reporting.
The classification of the event as an injury regarding an MRI-compatible implantable device necessitates careful review of performance data. While specific failure modes are not detailed in the source, such reports typically lead to internal investigations to determine if the event was related to device malfunction, off-label use, or procedural complications.
Regulatory and quality teams should ensure post-market surveillance protocols for these specific models are active and that any incoming adverse event reports are triaged for potential signal detection or trend analysis.
Event type: Injury. Device: COBALT¿ XT DR MRI SURESCAN¿ by MEDTRONIC EUROPE SARL.
Open in openFDA / FDA.gov