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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Healthcare provider (hcp) called for help trying to connect to implantable neurostimulator (ins) to turn back on following a procedure.The communicator and handset appeared to be connected to one another but when hcp attempts to connect handset to patient's ins, they only see 'no device response'.Agent eventually asked if the procedure was a cardioversion and hcp indicated yes.Provider stated they only turned ins off and it was not programmed into a specific cardioversion group.Agent advised they consider reaching local rep.Mdt rep called back to report that the patient had a cardioversion today and turned ins off and following procedure cannot turn therapy back on using the patient handset.Technical services (ts) reviewed with rep to interrogate the ins with the clinician tablet to confirm no telemetry with the ins today.Rep asked about resetting the ins, ts reviewed resetting the ins will not correct the situation but they are welcome to try.No symptoms were reported.
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