CapSure Fix MRI (Medtronic Puerto Rico Villalba) — Malfunction
The FDA reported a device malfunction involving the CapSure Fix MRI, manufactured by Medtronic Puerto Rico Villalba. The source identifies the event as a malfunction but does not specify the exact nature of the mechanical or electrical failure.
This affects Medtronic Puerto Rico Villalba, manufacturers of MRI-compatible implantable leads, and regulatory/QA professionals responsible for post-market surveillance of cardiac rhythm management devices.
While the source provides limited detail on the specific failure mode, reports of malfunctions in MRI-compatible leads may indicate potential risks to device integrity or patient safety during imaging procedures. Regulatory teams may need to monitor for trends in similar malfunction reports to determine if CAPA or design-change interventions are necessary.
Ensure that all reported malfunctions for MRI-compatible leads are captured in the firm's complaint management system. Review existing risk files to confirm that the observed failure modes are within the established occurrence limits for these components.
Event type: Malfunction. Device: CapSure Fix MRI by Medtronic Puerto Rico Villalba.
Open in openFDA / FDA.gov