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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient reported that they noticed a "bump" and that they believed the implantable cardiac monitor (icm) was "sticking out." eight months later, the bump remained and the device was explanted.After the device was removed, the patient developed an infection whiich was described as a "deep wound and pus." no further patient complications have been reported as a result of this event.
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