MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Break (1069); High impedance (1291); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2023 |
Event Type
Injury
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that one contact on the electrode had high impedance that was essential for the stimulation, electrode needed to be replaced.During replacement, because of the hooks on the lead, explant was challenging and the lead broke.The issue resolved with the new lead.The patient was alive with no injury.
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Manufacturer Narrative
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Continuation of concomitant medical products: product id: 09100, serial#: unknown, explanted: (b)(6) 2023, product type.The main component of the system.Other relevant device(s) are: product id: 09100, serial/lot #: unknown.(b)(6).Codes belong to the lead.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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Manufacturer Narrative
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D9 and h3 updates pertain to the lead.Continuation of d10: product id 09100-60 lot# serial# unknown implanted: explanted: (b)(6) 2023 product type lead.H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.H3.Other: device analysis is presently ongoing.H6 codes pertain to the lead.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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Manufacturer Narrative
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Continuation of d10: product id: 09100-60, serial# unknown, explanted: (b)(6) 2023, product type: lead.H3 updates pertain to the lead.H3 device evaluation: analysis found that the conductor 0 was broken at 19.5 cm from the distal end in the body of the lead in the electrode area; the conductors were stretched and the conductor coils were crushed.Analysis noted that conductor 0 was broken in the electrode area in the body of the lead due to overstress/damage and conductor 2 was broken at the weld site of electrode 2 at 4.9 cm from the distal end due to overstress damage.There was an impression in the lead body consistent with a suture having been tied around the body of the lead; the lead was returned with the suture.There was torn insulation under electrodes 1, 2, <(>&<)> 3.The distal end was stretched; there was distortion on all four of the windings of the electrode assembly.Continuity was acceptable for 1 and 3, but there was a short between circuits 0 and 1.Open circuits were found on 0 and 2.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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