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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 DR

Models E110/E111/F110/F111

TELIGEN DR
Models E110/E111/F110/F111
Worldwide Distribution:75,000
Worldwide Confirmed Malfunctions:74
Without Compromised Therapy With Compromised Therapy Total
Electrical81321
108Safety Core-electrocautery1-
110High-voltage capacitor-3
115Low-voltage capacitors2-
119Integrated circuit510
Mechanical92938
2Subpectoral implant 2009-3
101Transformer-9
105Seal plug2-
106Difficulty securing lead68
113Header contacts19
Software7-7
117Fault codes not displayed post-EOL3-
120Memory errors4-
Other628
Non-patterned62
WW Confirmed Malfunctions 304474

More details about malfunctions

References cited in table above