This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: during analysis it was noted that the programmer had a worn lower case and a loose electrocardiogram connector on the link electronic module (lem), both were replaced and additionally the lem was calibrated, and that the software was reconfigured, reloaded and updated software.(b)(4).
|