TPLC - Total Product Life Cycle

• Device: stimulator, spinal-cord, totally implanted for pain relief
• Product Code: LGW
• Device Class: 3

Premarket Approvals (PMA)
2015	2016	2017	2018	2019	2020
72	92	94	64	69	32

Device Problems
Adverse Event Without Identified Device or Use Problem	27892
Charging Problem	12982
Device Operates Differently Than Expected	9425
High impedance	7846
Battery Problem	7367
Failure to Deliver Energy	6682
Communication or Transmission Problem	5664
Insufficient Information	5236
Migration or Expulsion of Device	5089
Device Displays Incorrect Message	3585
Improper or Incorrect Procedure or Method	3563
Inappropriate Shock	3345
Unintended Collision	3320
Premature Elective Replacement Indicator	3282
Unexpected Therapeutic Results	3146
Use of Device Problem	3103
Therapeutic or Diagnostic Output Failure	3025
Migration	2955
Failure to Interrogate	2898
Energy Output Problem	2309
Low Battery	2178
No Device Output	2164
Delayed Charge Time	2094
Intermittent Continuity	2048
Therapy Delivered to Incorrect Body Area	1832
Malposition of device	1765
Break	1623
Overheating of Device	1622
Wireless Communication Problem	1600
Device Inoperable	1508
Impedance Problem	1352
Fracture	1296
Connection Problem	1254
Patient Device Interaction Problem	1146
Electromagnetic Compatibility Problem	1136
No Apparent Adverse Event	1129
Premature Discharge of Battery	1080
Failure to Charge	977
Unstable	954
Material Integrity Problem	900
Positioning Problem	845
Low impedance	787
Electromagnetic Interference	764
Application Program Freezes, Becomes Nonfunctional	653
Display or Visual Feedback Problem	464
Disconnection	416
Energy Output To Patient Tissue Incorrect	397
Defective Device	378
Device Or Device Fragments Location Unknown	322
Pocket Stimulation	260
Data Problem	254
Improper Device Output	225
Device Difficult to Program or Calibrate	197
Material Deformation	194
Patient-Device Incompatibility	179
Failure to Power Up	172
Premature End-of-Life Indicator	164
Telemetry Discrepancy	161
Loss of Data	159
Device Dislodged or Dislocated	140
Kinked	132
Temperature Problem	130
Difficult to Remove	129
Bent	128
Shipping Damage or Problem	122
Environmental Compatibility Problem	115
Difficult to Insert	114
Human-Device Interface Problem	108
Device Contamination with Chemical or Other Material	98
Unable to Obtain Readings	96
Inadequacy of Device Shape and/or Size	84
Detachment of Device or device Component	78
Material Frayed	77
Inadequate Instructions for Non-Healthcare Professional	68
Material Separation	62
Component Missing	58
Material Split, Cut or Torn	55
Device Stops Intermittently	55
Unexpected Shutdown	53
Intermittent Energy Output	46
Appropriate Term/Code Not Available	45
Material Protrusion / Extrusion	42
Electro-Static Discharge	39
Vibration	38
Material Fragmentation	38
Noise, Audible	34
Material Twisted / Bent	34
Unintended Movement	31
Power Problem	30
Degraded	30
Ambient Noise Problem	29
Failure to Fire	27
Device Issue	25
Device Damaged by Another Device	22
Shelf Life Exceeded	21
Failure to Align	20
Operating System Becomes Nonfunctional	19
Labelling, Instructions for Use or Training Problem	18
Mechanical Problem	17
Application Program Problem	14
Total Device Problems	161884

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Neuromodulation Corporation	II	May-26-2020
2	Medtronic Neuromodulation	II	Jul-13-2018
3	Medtronic Neuromodulation	II	Jun-07-2016
4	Medtronic Neuromodulation	II	Feb-23-2016
5	Medtronic Neuromodulation	II	Jun-26-2015
6	Nuvectra	II	Dec-17-2016
7	Nuvectra	II	May-03-2016
8	QiG Group LLC	II	Mar-18-2016
9	St. Jude Medical, Inc.	II	Oct-17-2017
10	St. Jude Medical, Inc.	II	Jul-07-2017