| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01086-1 |
| Product Name/Description |
Optisure Dual Coil Defibrillation Leads
(Lead, defibrillator/pacemaker, implantable)
Model Numbers: LDA220Q/52, LDA220Q/58, LDA220 Q/65 and LDP 220Q/58
ARTG Numbers: 221010, 221013 and 221011 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
St. Jude Medical has become aware of a small number of Optisure Dual Coil Defibrillation leads that may have had potential insulation damage at the interface of the termination sleeve and SVC shock coil in Optisure Dual Coil Defibrillation leads. This damage has been determined to have occurred during the manufacturing process.
In the event that a subject Optisure lead is connected to a device without Dynamic Tx technology, there is the potential for lead damage to result in loss of defibrillation therapy during attempted shock delivery when programmed to the RV to SVC and can high voltage therapy configurationSt. Jude Medical is not aware of any complaints or clinical incidents related to this matter. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Customers are asked to quarantine all unused units prior to return to St Jude Medical. For affected units that have been implanted, St Jude Medical is advising that patients should continue to be managed in accordance with the patient management protocol included in the customer letter. For further information, please see http://www.tga.gov.au/alert/optisure-dual-coil-defibrillation-leads This action has been closed-out on 22/08/2016. |
| Contact Information |
(02) 9936 1214 - Sales Manager |