TPLC - Total Product Life Cycle

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Device	catheter, recording, electrode, reprocessed
Regulation Description	Electrode recording catheter or electrode recording probe.
Definition	Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product Code	NLH
Regulation Number	870.1220
Device Class	2

Premarket Reviews
Manufacturer	Decision
INNOVATIVE HEALTH
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE HEALTH, LLC.
	SUBSTANTIALLY EQUIVALENT	4
STERILMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SUSTAINABILITY SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC.
	SUBSTANTIALLY EQUIVALENT	4
1. K221067 Medline ReNewal Reprocessed St. Jude Medical Livew ...
2. K240972 Medline ReNewal Reprocessed Medtronic Achieve Cath ...
3. K241156 Medline ReNewal Reprocessed St. Jude Medical Respo ...
4. K242225 Medline ReNewal Reprocessed Abbott Inquiry Steerab ...
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC.(DBA MEDLINE REN
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	71	71
Mechanical Problem	51	51
Material Deformation	33	33
Mechanical Jam	28	28
Shipping Damage or Problem	10	10
Patient Device Interaction Problem	9	9
Break	7	7
Difficult to Open or Remove Packaging Material	7	7
Inadequacy of Device Shape and/or Size	7	7
Signal Artifact/Noise	6	6
Deformation Due to Compressive Stress	6	6
Material Separation	6	6
Entrapment of Device	4	4
Device Reprocessing Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Positioning Problem	3	3
Electrical /Electronic Property Problem	2	2
Fracture	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Twisted/Bent	2	2
Positioning Failure	2	2
Contamination /Decontamination Problem	2	2
Defective Device	2	2
Insufficient Information	2	2
Energy Output Problem	2	2
Stretched	1	1
Difficult to Remove	1	1
Structural Problem	1	1
Contamination	1	1
Therapeutic or Diagnostic Output Failure	1	1
Packaging Problem	1	1
Device Handling Problem	1	1
Material Integrity Problem	1	1
Defective Component	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Failure to Advance	1	1
Unintended Movement	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Disconnect	1	1
Physical Resistance/Sticking	1	1
Activation, Positioning or Separation Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	146	146
Insufficient Information	15	15
No Consequences Or Impact To Patient	13	13
Cardiac Tamponade	8	8
Pericardial Effusion	7	7
No Known Impact Or Consequence To Patient	5	5
Cardiac Perforation	5	5
Abdominal Pain	3	3
Low Blood Pressure/ Hypotension	3	3
Failure of Implant	1	1
Vascular Dissection	1	1
Tricuspid Valve Insufficiency/ Regurgitation	1	1
Perforation	1	1
Anemia	1	1
Atrial Fibrillation	1	1
Rupture	1	1
Foreign Body In Patient	1	1
Chest Pain	1	1
Discomfort	1	1
Tachycardia	1	1
Cough	1	1
Tricuspid Regurgitation	1	1
Loss of consciousness	1	1
Internal Organ Perforation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-26-2025
2	Stryker Sustainability Solutions	II	Jul-03-2024