Medtronic recently identified an issue with a connector bracket weld on a subset of Consulta® CRT-P models C3TR01, C4TR01, and Syncra® CRT-P model C2TR01 devices manufactured between April 1 and May 13, 2013. Medtronic records indicate you have implanted one or more devices from this subset. Please see the attached list for your specific serial numbers. Please note, this type of connector bracket weld is unique to Consulta and Syncra CRT-P devices and no other Medtronic device models are affected.
This issue was identified as a result of an internal investigation into a recent trend of increasing manufacturing rejects related to the connector bracket weld. An out-of-specification weld could result in a loss of device hermeticity and compromised device functionality. As of June 21, 2013, there have been no reported or confirmed device failures or patient injuries. We estimate the rate of out-of-specification welds to be 1-2% in this subset of devices.
Loss of hermeticity may allow body fluids to enter the device. This has the potential to compromise functionality resulting in loss of output. Loss of pacing output may result in a return of bradycardia or heart failure symptoms (e.g. fainting or lightheadedness; dyspnea, fatigue or edema respectively). In rare cases involving pacemaker-dependent patients, loss of pacing output may result in death or serious injury
Non-implanted devices from this subset have been recalled and are being returned to Medtronic for re-inspection with additional controls to ensure that the weld meets specification; however, up to 779 devices worldwide (43 in the U.S.) may have been implanted from this subset. We realize that each patient requires unique clinical consideration and we support your judgment in caring for your patients. As a result of our on-going investigation and consultation with Medtronic’s Independent Physician Quality Panel, Medtronic now offers the following patient management recommendations:
We are committed to providing you with ongoing updates in our Product Performance Report available at: http://wwwp.medtronic.com/productperformance/.
We regret any difficulties this may cause you and your patients. Please be assured that patient safety and product quality remain our primary concern. If you have any questions, or if we can be of assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management