MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 03/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical product: product id: 97745, lot/ serial#: (b)(4), product type: programmer 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 external device.The reason for call was pt reported that the beginning of 03/21 they began feeling unexpected, increased stimulation.Pt stated that sometimes they feel stimulation even when their stimulation is off.Pt also mentioned that today, they noticed that there is a rattling sound coming from inside the controller.Patient services redirected pt to their healthcare professional (hcp) if unexpected stimulation continues after receiving the replacement controller.Upon further review, pt stated that sometimes they will check implant with the controller and it will say stimulation is off, but they did not turn stimulation off.Pt also stated that the controller battery was not depleted.Additional information received reported that the only thing patient told rep was that their ears were ringing post covid.Rep asked patient to call their doctor or pats.Rep confirmed they were never made aware of the stim/device turning off or any other device/therapy issues.
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Event Description
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Additional information was received.It was reported the circumstances that led to the unexpected, increased stimulation was the patient experienced excessive stimulation to their neck.Even when the controller was off, and the controller would show off when the patient had not turned it off.The patient was sent a new device and the issue was resolved.
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Manufacturer Narrative
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Continuation of d10: product id 97745 serial# (b)(6) product type programmer, patient.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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