MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 7427 |
Device Problems
Energy Output Problem (1431); Data Problem (3196)
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Patient Problems
Device Overstimulation of Tissue (1991); Pain (1994)
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Event Date 07/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for other pain indications - other.The patient (pt) mentioned their ins may need to be reprogrammed because the pt had some back pain and turned their therapy on, but the therapy was "way too strong" and was "out of balance" since about a could of weeks ago.Pt said the "setting were all messed up." the patient was redirected to their healthcare provider to further address the issue.Pt was also provided the number to nas.
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Event Description
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Additional information was received from the patient clarifying the report of the ¿therapy was out of balance¿ by stating that the ¿unit that he hand held control was out of normal therapy and the patient could not use the product¿.Circumstances that led to the therapy being way too strong, ¿out of balance¿ and the settings being all messed up was a change to the device programming.The cause of the issue was not determined.The patient reported that they need to have their doctor have a manufacturer representative (rep) there at their next appointment.
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Manufacturer Narrative
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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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