MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97725 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Headache (1880)
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Event Date 01/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 977d260, serial#: unknown, implanted: (b)(6) 2021, product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: unknown.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 via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins).It was reported that the patient underwent insertion of trial cervical lead.She says headache started the evening she had the procedure.The physician treated this incident as a possible spinal fluid leak and advised fluids and caffeine intake. pt refused to have lead removed on (b)(6), but will allow hcp to remove lead on (b)(6).The rep had her turn stimulator off for now.The issue was not yet resolved.On (b)(6) 2021, additional information was received from the manufacturer representative (rep) reporting that the cause of the patient¿s headaches per the patient¿s doctor was assumed to be due to a csf leak.No csf leak had been noted when the leads were placed.The healthcare provider (hcp) performed a blood patch on the patient and the patient was feeling somewhat better.It was reported that the customer disposed of the wens and lead pull and therefore the devices would not be returned for analysis.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.
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Event Description
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The representative stated that according to the physician the patient¿s headache had improved since the blood patch.
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Manufacturer Narrative
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Continuation of d10: product id 977d260 lot# serial# (b)(6) implanted: explanted: product type screening device product id 977d260 lot# serial# (b)(6) implanted: 2021-(b)(6) explanted: product type screening device 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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