MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Intermittent Continuity (1121); Energy Output Problem (1431); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 (pt) regarding an implantable neurostimulator (ins).The reason for call was that saturday night they were laying in bed around 11 o'clock at night when all of a sudden the therapy intensified.Pt stated that they hadn't touched the controller or even have the controller near them when it happened.Pt stated that their wife used the controller to turn the ins off.Pt stated that just now the same issue occurred when they were walking into their bedroom and then sitting on their couch.Pt confirmed that they didn't have adaptivestim enabled/active.Pt noted that they had groups a, b, c and d available with programs 1, 2, 3 and 4 available on each group.Pt stated that they hadn't switched groups in at least two months.Pt stated that they just tapped on group a and the ins went haywire.The patient was redirected to their healthcare provider (hcp) to further address the is sue.
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Event Description
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Additional information from the patient indicated that their stimulator was reprogrammed from "abcd" to abc.They stated that the "electrodes moved slightly" but the stimulator was "reset." the issue was resolved.
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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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