FDA.reportPublic FDA data

DBS ™

Primary DI
00643169313552
Brand
DBS ™
Company
MEDTRONIC, INC.
Model
3391S-40
Device description
LEAD 3391S-40 PSYCH DBS OCD HDE EMAN
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MFRStimulator, brain, implanted, for behavior modification
OLMDeep brain stimulator for obsessive compulsive disorder (OCD)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFRStimulator, Brain, Implanted, For Behavior ModificationUnknownf
OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)Unknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H050003060

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H050003060

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169313552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169313552006431693135526431693135520643169313552

GMDN Terms#

Term, Definition table
TermDefinition
Neural-tissue electrical stimulation leadA sterile metal wire, insulated with non-conductive material except at its electrode(s), intended to be implanted in neural tissue to enable an electrical connection typically with an external pulse generator (EPG) [e.g., a spinal cord stimulation (SCS) or a deep brain stimulation (DBS) stimulator] that will provide the required tissue stimulation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-34 Degrees Celsius57 Degrees Celsius
Handling Environment Temperature-30 Degrees Fahrenheit135 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
796986144
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.OLM2026-08-07
00199309002416N/AMEDTRONIC, INC.OLM2026-05-29
00199150006045N/AMEDTRONIC, INC.OLM2026-02-02
00763000994198N/AMEDTRONIC, INC.OLM2025-10-19
00763000975029N/AMEDTRONIC, INC.OLM2025-03-07
00763000963040N/AMEDTRONIC, INC.OLM2025-02-17
00763000963057N/AMEDTRONIC, INC.OLM2025-02-17
00643169955653N'VISION®MEDTRONIC, INC.OLM2024-10-04
00763000924621Activa® SCMEDTRONIC, INC.OLM2024-05-30
00763000924614Activa® SCMEDTRONIC, INC.OLM2024-05-27
00763000916268Percept™ PC BrainSense™MEDTRONIC, INC.OLM2024-04-21
00763000662028N/AMEDTRONIC, INC.OLM2024-03-03
00763000640033N/AMEDTRONIC, INC.OLM2024-01-22
00763000523312N/AMEDTRONIC, INC.OLM2024-01-19
00763000523329N/AMEDTRONIC, INC.OLM2024-01-19
00763000875725NAMEDTRONIC, INC.OLM2023-12-09
00763000875718NAMEDTRONIC, INC.OLM2023-11-16
00763000875862N'VISION™MEDTRONIC, INC.OLM2023-11-16
00763000642174Percept™ PC BrainSense™MEDTRONIC, INC.OLM2023-01-15
00763000404413N/AMEDTRONIC, INC.MFR2022-05-02
00763000404413N/AMEDTRONIC, INC.OLM2022-05-02
00763000274412DBS™MEDTRONIC, INC.OLM2021-12-16
00763000519216Percept™ PC BrainSense™MEDTRONIC, INC.OLM2021-10-17
00763000519223Activa® SCMEDTRONIC, INC.OLM2021-10-17
00763000519230Activa® SCMEDTRONIC, INC.OLM2021-10-17
00763000411916N/AMEDTRONIC, INC.OLM2021-07-30
00763000424107N/AMEDTRONIC, INC.OLM2021-04-18
00763000424114N/AMEDTRONIC, INC.OLM2021-04-18
00763000420994N/AMEDTRONIC, INC.OLM2020-12-21
00763000384326Activa® PCMEDTRONIC, INC.OLM2020-11-22