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Permanent Pacemaker Electrode
FDA product code DTB · Class 3 · Cardiovascular
448
Registered devices
325,342
Adverse events
8
Recalls
487
510(k) clearances
Devices with this code
CAPSURE SP NOVUS® — MEDTRONIC, INC.Sprint Quattro Secure S MRI™ SureScan™ — MEDTRONIC, INC.NA — MEDTRONIC, INC.Capsurefix® Novus — MEDTRONIC, INC.CapSure Sense® — MEDTRONIC, INC.CapSure Sense® — MEDTRONIC, INC.VV-PLUG — Oscor Inc.SPRINT QUATTRO® — MEDTRONIC, INC.CapSureFix Novus MRI™ SureScan™ — MEDTRONIC, INC.Sprint Quattro Secure® — MEDTRONIC, INC.Sprint Quattro Secure S® — MEDTRONIC, INC.CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.ATTAIN® PERFORMA™ S — MEDTRONIC, INC.Attain Performa™ MRI SureScan™ — MEDTRONIC, INC.NA — MEDTRONIC, INC.CapSure Sense MRI™ SureScan™ — MEDTRONIC, INC.Attain Ability® Straight — MEDTRONIC, INC.CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.Sprint Quattro Secure™ — MEDTRONIC, INC.Attain Ability™ Straight MRI SureScan™ — MEDTRONIC, INC.FINELINE® II Sterox — BOSTON SCIENTIFIC CORPORATIONNA — MEDTRONIC, INC.CAPSUREFIX® NOVUS — MEDTRONIC, INC.Sprint Quattro Secure® — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-09-15 | Medtronic Inc. Cardiac Rhythm Disease Management | Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when |
| 2010-05-13 | Greatbatch Medical | The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipola |
| 2010-02-25 | Medtronic Inc. Cardiac Rhythm Disease Managment | Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that specific package seals could be compromised. Med |
| 2009-09-01 | Greatbatch Medical | The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the perfo |
| 2009-09-01 | Greatbatch Medical | The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the perfo |
| 2008-01-29 | Oscor, Inc. | The O-rings are over tolerance making it hard to connect the leads to the pacemaker. |
| 2006-07-18 | Enpath Medical, Inc | The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could caus |
| 2006-07-18 | Enpath Medical, Inc | Enpath Lead Adapters: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial |
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