MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Failure to Interrogate (1332); Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problems
Device Overstimulation of Tissue (1991); Electric Shock (2554); Insufficient Information (4580)
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Event Date 11/12/2021 |
Event Type
malfunction
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Event Description
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Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for spinal pain.Manufacturer representative (rep) reports he spoke to patient today.Patient indicated he has been having shocking sensation all over his body even when he bends down to pick up his cat.Caller reports the shocking sensation started about 1 week ago, but then patient mention yesterday after clarification was asked.Caller reports patient conference his wife and wife indicated the shocking sensation has been awhile, unknown if its stimulation vs shocking sensation.Wife indicated when patient goes to bed, the stimulation is strong and have to turn stimulation off at night.Caller reports patient have not been charging his device for a week and the controller unable to communicate with his implant. caller reports patient had difficulty charging his implant for a month, ins protruding out and cannot get connection so patient had given up on charging.Caller reports stimulation is off and continues to feel shocking sensation all over his body.Caller reports indicated he fell wednesday night due to his left leg being numbed and feeling dead, caller do not known how patient landed or if he caught himself before he fell.Caller reports patient had an appointment with dr.(b)(6) but was cancelled, unknown reason why cancelled.Redirect caller to patient's hcp.
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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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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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Additional information was received on december 15, 2021.The rep reported that on (b)(6) 2021, the patient had an appointment with their doctor for a radio frequency ablation (rfa) procedure, and the patient hadn't mentioned any of the scs complaints to the physician.The physician was not made aware of the patient's concerns until after the rf ablation procedure, so no plans have been made yet to address the scs issues the patient previously reported.Additionally, the physician reported that nothing appeared abnormal about the ins positioning; they did not see the ins protruding when they did the rf ablation procedure.Patient weight was provided.
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Search Alerts/Recalls
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