This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient came to the hospital after receiving multiple inappropriate shocks.Interrogation showed oversensing, high pacing impedance and a failure to capture.The lead was suspected to have an impending fracture.When the device was removed from the pocket, it was noted that the lead was coiled into a very tight redundant coil.The lead was explanted and replaced.The patient is part of a lawsuit alleging that the lead is inherently defective and that the patient may have suffered damages and losses including, but not limited to: emotional distress, including mental distress, anger, depression and anxiety.No further patient complications have been reported as a result of this event.
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