MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Overheating of Device (1437); Environmental Compatibility Problem (2929)
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Patient Problems
Burn(s) (1757); Unspecified Infection (1930); Burning Sensation (2146)
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Event Type
Injury
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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 regarding their implantable neurostimulator (ins).Information was reported that the patient had their battery changed in november, so their incision site is fully healed, however the patient has been experiencing severe burning right there at the battery.Their meds don't cover it, and it hurts to the touch.The patient is not sure what to do as they don¿t want to go out during covid19.No further complications were reported.No additional patient symptoms were reported.
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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.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 reported that the cause of the cause of the patient's burning was coming from inside where the battery is due to charging it while being outside in the sun.The heat burnt the inside of the patient.The patient was provided a round of antibiotics for ten days four times a day, and that cleared up the burn inside that got infected.The burning has been resolved.The patient noted their symptoms cleared up around two weeks ago.
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Search Alerts/Recalls
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