PRODUCT OR MODEL UNK

Description of Event or Problem

MEDTRONIC CARDIOVASCULAR RECEIVED INFORMATION THROUGH A LEGAL REPRESENTATION, ALLEGING AN OCTOPUS DEVICE MALFUNCTIONED AND DESTABILIZED, CAUSING EROSION INTO THE PATIENT'S RIGHT VENTRICLE. THIS WAS ALLEGED TO CAUSE SERIOUS COMPLICATIONS RESULTING IN THE PATIENT'S DEATH.

Additional Manufacturer Narrative

THE MODEL AND SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED, AND NO PRODUCT IS EXPECTED TO BE RETURNED. DEVICE HISTORY REVIEW AND ANALYSIS CAN NOT BE PERFORMED. RESULTS: DEVICE HISTORY REVIEW AND ANALYSIS CANNOT BE PERFORMED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. NO PRODUCT WAS RETURNED FOR ANALYSIS. CONCLUSION: THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RECEIPT, THIS EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT FILED.