CRM Product Performance Report Q3 2010

COGNIS

COGNIS
Models N118/N119/N120/P106/P107/
P108

Worldwide Distribution:50,000
Worldwide Confirmed Malfunctions:63

		Without Compromised Therapy	With Compromised Therapy	Total
Electrical		18	2	20
106	Safety Core-electrocautery	12	-
108	High-voltage capacitor	-	1
113	Low-voltage capacitors	4	-
116	Capacitor	-	1
118	Integrated circuit	2	-
Mechanical		10	19	29
1	Subpectoral implant 2009 (Advisory issued)	-	7
99	Transformer	-	1
104	Difficulty securing lead	8	8
111	Header contacts	1	2
119	Header	1	1
Software		2	-	2
112	Safety Core-programming	1	-
116	Fault codes not displayed post-EOL	1	-
Other		8	4	12
	Non-patterned	8	4
WW Confirmed Malfunctions		38	25	63

More details about malfunctions

References cited in table above