It was reported that the mobile programmer was in use during an implant procedure when a implantable pulse generator (ipg) exhibited a device reset.The reason for reset was unknown.It was further noted that the patient was undergoing an ipg change procedure when the user proceeded to perform device based testing with the mobile programmer which was already connected to the implanted device via a bluetooth connection.When the user initiated the lead impedance test, the programmer immediately gave a message that "the ipg had undergone an electrical reset, battery voltage was unavailable though the programmed device parameters were unchanged".The user then cleared the device reset and proceeded with further device testing and final programming.The "remaining longevity" gauge displayed greyed-out and indicated "pre-implant".The mobile programmer remains in use.No patient complications have been reported as a result of this event.
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Product analysis: analysis of the mobile application logs was performed and no anomalies were found.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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