MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Energy Output Problem (1431); Low impedance (2285)
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Patient Problems
Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id 977a260, serial# (b)(6), product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6), ubd: 28-jun-2025, udi#: (b)(4).G2.Foreign: japan.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 consumer via a manufacturer¿s representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use it was reported that an attempt was made to increase the stimulation, however, it could not be increased, and the message "settings disabled" was displayed.The stimulation could be lowered, but it could not be increased.Both the ins and controller were said to have more than 60% charge.The group was set to only a and could not be changed to another group.The stimulation intensity was 1, so when an attempt was made to increase it, the setting value was disabled; the situation was heard where it was lowered to 0.6, and it could not be increased.Please consult with the medical institution and obtain their approval.Patient health damage was reported (pain is subdued with medication), and the issue has not resolved.Additional information was received.Ins serial #, model #, and implant date, and controller serial # confirmed.It was confirmed that the cause of ¿settings disabled / unable to increase stim" was high impedance of setting electrode.The electrode with abnormal impedance was removed and the setting was changed.The issue has currently resolved.Additional information was received.It was confirmed that the abnormal electrode was resolved by programming, device remains implanted.Regarding the electrode in question, the impedance value was 250o.Ins lead information provided along with implant date of the lead.
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