TPLC - Total Product Life Cycle

show TPLC since

Device	recorder, event, implantable cardiac, (with arrhythmia detection)
Product Code	MXD
Regulation Number	870.1025
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOTRONIK, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOTRONIK, INC.
	SUBSTANTIALLY EQUIVALENT	9
BOSTON SCIENTIFIC CORP
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	12
MEDTRONIC,INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC. INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Reset Problem	1030	1030
Adverse Event Without Identified Device or Use Problem	870	870
Inappropriate or Unexpected Reset	632	632
Signal Artifact/Noise	626	626
Under-Sensing	605	605
Output Problem	602	602
Over-Sensing	472	472
Device Sensing Problem	467	467
Migration or Expulsion of Device	453	453
Premature Discharge of Battery	217	217
Communication or Transmission Problem	203	203
Data Problem	184	184
Failure to Interrogate	156	156
Electromagnetic Interference	134	134
Unable to Obtain Readings	111	111
Mechanical Problem	111	111
Premature Elective Replacement Indicator	60	60
Ambient Noise Problem	57	57
Failure to Sense	51	51
Decreased Sensitivity	47	47
Appropriate Term/Code Not Available	45	45
Migration	43	43
Battery Problem	41	41
Device Dislodged or Dislocated	35	35
False Positive Result	26	26
Device-Device Incompatibility	24	24
Device Displays Incorrect Message	18	18
Failure to Read Input Signal	17	17
Loss of Data	16	16
Expulsion	12	12
Malposition of Device	11	11
Failure to Transmit Record	11	11
Material Integrity Problem	8	8
Break	8	8
Battery Problem: High Impedance	7	7
Premature End-of-Life Indicator	7	7
Difficult to Insert	7	7
Positioning Problem	7	7
Difficult to Remove	6	6
Off-Label Use	6	6
Failure to Analyze Signal	5	5
Use of Device Problem	5	5
Human-Device Interface Problem	5	5
Insufficient Information	5	5
No Apparent Adverse Event	4	4
Device Damaged by Another Device	4	4
Application Program Problem	4	4
Difficult or Delayed Positioning	4	4
Protective Measures Problem	4	4
Connection Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4865	4865
Unspecified Infection	350	350
Wound Dehiscence	336	336
Discomfort	153	153
Pocket Erosion	137	137
Pain	111	111
Erosion	104	104
No Known Impact Or Consequence To Patient	97	97
Implant Pain	87	87
Erythema	39	39
Impaired Healing	25	25
Hemorrhage/Bleeding	23	23
Purulent Discharge	22	22
Hematoma	21	21
No Consequences Or Impact To Patient	20	20
Swelling/ Edema	19	19
Hypersensitivity/Allergic reaction	18	18
Twiddlers Syndrome	16	16
Insufficient Information	16	16
Skin Inflammation/ Irritation	13	13
Inflammation	13	13
No Code Available	10	10
Fluid Discharge	10	10
Itching Sensation	9	9
Failure of Implant	7	7
Burning Sensation	7	7
Rash	7	7
Bacterial Infection	6	6
Chest Pain	6	6
Twiddlers Syndrome	5	5
Skin Erosion	5	5
Bruise/Contusion	4	4
Abscess	4	4
Fever	4	4
Cellulitis	4	4
Cardiac Arrest	4	4
Sepsis	4	4
Arrhythmia	4	4
Patient Problem/Medical Problem	3	3
Atrial Fibrillation	3	3
Perforation	3	3
Anxiety	3	3
Unspecified Tissue Injury	3	3
Swelling	2	2
Dyspnea	2	2
Laceration(s)	2	2
Scar Tissue	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Pneumothorax	2	2
Pressure Sores	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc.	II	Dec-01-2023
2	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Mar-11-2022
3	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Jul-20-2021
4	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Jul-14-2021