Cardiovascular · PMA · 2025
Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I
Medtronic Cardiac Rhythm Disease Management. Approved by FDA on 28 October 2025 under submission P980016/S939, product code LWS (implantable cardioverter defibrillator (non-crt)). What FDA's record says, in FDA's words.
Device record · P980016/S939
- Device. Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IDEVICE
- Company. Medtronic Cardiac Rhythm Disease ManagementCOMPANY
- Decision. 28 October 2025, PMADECISION
- Panel. CardiovascularPANEL
- Product code. LWS, Implantable Cardioverter Defibrillator (Non-Crt)CODE
- Source. FDA database entrySOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
The product code's definition, from FDA's classification record. These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 382,884 reports filed against devices carrying product code LWS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · ENDOTAK RELIANCE · BOSTON SCIENTIFIC CORPORATION · report 2124215-2026-51894
30 September 2026 · Injury · Sprint Quattro Secure S MRI SureScan · Medtronic Puerto Rico Villalba · report 2649622-2026-28821
30 September 2026 · Malfunction · Sprint Quattro Secure S MRI SureScan · Medtronic Puerto Rico Villalba · report 2649622-2026-28822
30 September 2026 · Injury · Cobalt¿ VR MRI SureScan¿ · Medtronic Europe Sarl · report 9614453-2026-03924
It was reported that the Implantable Cardioverter Defibrillator (ICD) exhibited premature battery depletion. The device was explanted and replaced. No patient complications have been reported as a result of this event.
30 September 2026 · Injury · ENDOTAK RELIANCE S · BOSTON SCIENTIFIC CORPORATION · report 2124215-2026-51909
It was reported that this previously capped implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The previously capped implantable lead was explanted.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code LWS, in Cardiovascular, or approved in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.