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Worldwide Malfunctions

Before/During Implant Procedure During Explant Procedure
ICD Product Longevity
U.S. Reason for Out of Service

CRM Product Performance Report Q4 2011

TELIGEN VR

Models E102/E103/F102/F103

TELIGEN VR
Models E102/E103/F102/F103
Worldwide Distribution:50,000
Worldwide Confirmed Malfunctions:70
Without Compromised Therapy With Compromised Therapy Total
Electrical459
110High-voltage capacitor-1
115Low-voltage capacitors3-
119Integrated circuit14
Mechanical83644
2Subpectoral implant 200916
101Transformer-8
105Seal plug1-
106Difficulty securing lead-9
113Header contacts510
121Header13
Software5-5
3Respiratory Sensor Oversensing1-
117Fault codes not displayed post-EOL3-
120Memory errors1-
Other5712
Non-patterned57
WW Confirmed Malfunctions 224870

More details about malfunctions

References cited in table above