TPLC - Total Product Life Cycle

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Device	electrode, pacemaker, temporary
Product Code	LDF
Regulation Number	870.3680
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Pacing Problem	394	394
Break	134	134
Adverse Event Without Identified Device or Use Problem	96	96
Inflation Problem	74	74
No Pacing	74	74
Material Separation	55	55
Material Integrity Problem	31	31
Fracture	29	29
Detachment of Device or Device Component	25	25
Insufficient Information	23	23
Material Rupture	22	22
Deformation Due to Compressive Stress	19	19
Failure to Sense	18	18
Failure to Capture	17	17
Appropriate Term/Code Not Available	16	16
Detachment Of Device Component	16	16
Connection Problem	16	16
Burst Container or Vessel	15	15
Device Dislodged or Dislocated	14	14
Material Too Rigid or Stiff	14	14
Patient Device Interaction Problem	11	11
Material Frayed	11	11
Gas/Air Leak	10	10
Material Fragmentation	10	10
Failure to Infuse	10	10
Disconnection	10	10
Material Twisted/Bent	9	9
Fluid/Blood Leak	9	9
Leak/Splash	9	9
Material Puncture/Hole	8	8
Device Operates Differently Than Expected	8	8
Material Split, Cut or Torn	8	8
Device Sensing Problem	7	7
Deflation Problem	7	7
Accessory Incompatible	6	6
Use of Device Problem	6	6
Improper or Incorrect Procedure or Method	6	6
Over-Sensing	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Electrical /Electronic Property Problem	5	5
Nonstandard Device	5	5
Pacing Inadequately	5	5
Loss of Threshold	5	5
Defective Device	5	5
Fitting Problem	5	5
Difficult to Remove	5	5
Tear, Rip or Hole in Device Packaging	5	5
Component Missing	4	4
Material Deformation	4	4
Difficult to Insert	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	435	435
No Consequences Or Impact To Patient	315	315
No Known Impact Or Consequence To Patient	214	214
Cardiac Tamponade	63	64
Cardiac Perforation	60	60
Cardiac Arrest	35	36
Exposure to Body Fluids	31	31
Insufficient Information	28	28
No Information	28	28
Death	26	26
Arrhythmia	24	25
Pericardial Effusion	23	23
No Patient Involvement	17	17
Hemorrhage/Bleeding	15	15
Perforation	15	15
No Code Available	13	13
Ventricular Fibrillation	11	11
Device Embedded In Tissue or Plaque	11	11
Low Blood Pressure/ Hypotension	10	10
Foreign Body In Patient	10	10
Internal Organ Perforation	9	9
Bradycardia	8	8
Surgical procedure	8	8
Unspecified Infection	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Tachycardia	7	7
Atrial Fibrillation	7	7
Blood Loss	7	7
Asystole	5	5
Cardiopulmonary Arrest	5	5
Failure of Implant	4	4
Not Applicable	4	4
Complete Heart Block	4	4
Chest Pain	4	4
Loss Of Pulse	4	4
Heart Block	4	4
Unspecified Tissue Injury	3	3
Pain	3	3
Rupture	3	3
Dyspnea	3	3
Myocardial Infarction	3	3
Loss of consciousness	3	3
Erosion	3	3
Perforation of Vessels	2	2
High Blood Pressure/ Hypertension	2	2
Thrombosis	2	2
Increased Sensitivity	2	2
Pulmonary Embolism	2	2
Needle Stick/Puncture	2	2
Complaint, Ill-Defined	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Alto Development Corp	II	Jul-29-2019
2	Arrow International Inc	II	Jun-24-2009
3	European Custom Manufacturing B.V.	II	Feb-15-2012
4	Heart Sync, Inc	II	May-30-2013
5	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
6	Medtronic Inc	III	Apr-14-2009
7	Medtronic Inc., Cardiac Rhythm and Heart Failure	II	Sep-19-2016
8	Oscor, Inc.	I	Nov-08-2018
9	Oscor, Inc.	II	Oct-29-2012