Stimulator, Spinal-cord, Implanted (pain Relief)

Device Code: 3682

Product Code(s): GZB

Device Classification Information

• Device Type ID: 3682
• Device Name: Stimulator, Spinal-cord, Implanted (pain Relief)
• Regulation Description: Implanted Spinal Cord Stimulator For Pain Relief.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurostimulation Devices Psychiatry Branch (NSDP)
• Submission Type: 510(k)
• CFR Regulation Number: 882.5880 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GZB
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 17-15 ISO 14708-3 Second Edition 2017-04
  Implants For Surgery - Active Implantable Medical Devices - Part 3: Implantable Neurostimulators

Total Product Life Cycle

• Device Type ID: 3682
• Device: Stimulator, Spinal-cord, Implanted (pain Relief)
• Product Code: GZB
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Implanted Spinal Cord Stimulator For Pain Relief.
• CFR Regulation Number: 882.5880 [🔎]

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
ANCHOR INNOVATION MEDICAL (A.I.M.)
	SUBSTANTIALLY EQUIVALENT	1
ST. JUDE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
STIMWAVE TECHNOLOGIES INCORPORATED
	SUBSTANTIALLY EQUIVALENT	8

Device Problems
Adverse Event Without Identified Device Or Use Problem	10761
Device Operates Differently Than Expected	4165
High Impedance	1819
Impedance Problem	1322
Temperature Problem	1147
Communication Or Transmission Problem	949
Migration Or Expulsion Of Device	802
Use Of Device Problem	802
No Device Output	658
Low Impedance	515
Fracture	471
Charging Problem	454
Therapy Delivered To Incorrect Body Area	441
Device Inoperable	342
Disconnection	341
Failure To Charge	230
Unintended Movement	213
Device Displays Incorrect Message	197
Inappropriate Shock	155
Nonstandard Device	125
Insufficient Information	118
Break	114
Device Stops Intermittently	109
Difficult To Advance	88
Failure To Advance	70
Failure To Deliver Energy	62
Low Battery	59
Battery Problem	52
Kinked	43
Delayed Charge Time	42
Improper Or Incorrect Procedure Or Method	40
Malposition Of Device	38
Pocket Stimulation	36
Difficult To Insert	32
Unintended Collision	30
Detachment Of Device Component	29
Cut In Material	28
Failure To Interrogate	28
Intermittent Continuity	25
Self-Activation Or Keying	24
Connection Problem	21
Overheating Of Device	21
Positioning Problem	21
Fluid Leak	20
Premature Elective Replacement Indicator	19
Unstable	18
Difficult To Remove	17
Device Damaged By Another Device	17
Sticking	16
Electromagnetic Interference	15
Detachment Of Device Or Device Component	15
Material Integrity Problem	15
Material Frayed	12
Inadequacy Of Device Shape And/or Size	12
Material Fragmentation	11
Device Or Device Fragments Location Unknown	10
Electromagnetic Compatibility Problem	10
Premature Discharge Of Battery	9
Bent	9
Premature End-of-Life Indicator	9
Device Handling Problem	8
Energy Output To Patient Tissue Incorrect	8
Unexpected Therapeutic Results	7
Device Dislodged Or Dislocated	7
Material Deformation	7
Contamination / Decontamination Problem	6
Corroded	6
Material Twisted / Bent	6
Device Remains Activated	5
Shipping Damage Or Problem	5
Material Split, Cut Or Torn	5
Expulsion	5
Material Separation	5
Battery Problem: Low Impedance	5
Battery Problem: High Impedance	4
Appropriate Term/Code Not Available	4
Difficult To Open Or Close	4
Arcing Of Electrodes	4
Improper Device Output	4
Loss Of Data	3
Operating System Becomes Nonfunctional	3
Patient Device Interaction Problem	3
Device Contamination With Chemical Or Other Material	3
Leak / Splash	3
Inadequate Instructions For Non-Healthcare Professional	3
Torn Material	3
Incorrect, Inadequate Or Imprecise Result Or Readings	3
Display Or Visual Feedback Problem	3
Device Expiration Issue	3
Computer Software Problem	3
Failure To Conduct	3
Moisture Or Humidity Problem	3
Loose Or Intermittent Connection	2
Material Erosion	2
Device Damaged Prior To Use	2
Failure To Disconnect	2
Difficult To Position	2
Failure To Shut Off	2
Split	2
Accessory Incompatible	2
Total Device Problems	27433

Recalls
Manufacturer		Recall Class	Date Posted
1	St. Jude Medical, Inc.	II	Sep-29-2014

TPLC Last Update: 2019-04-02 20:34:26