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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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| Model Number 97715 |
| Device Problems
High impedance (1291); Low impedance (2285); Malposition of Device (2616)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/08/2021 |
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Event Type
malfunction
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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 manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was caller stated intra-operatively they tested impedances on newly implanted leads with a wireless external neurostimulator (wens) and all were green with electrode impedances and check connectivity.When ins was connected to leads, there was one contact on 0-7 lead and one contact on 8-15 lead that were high.Rep stated in recovery, impedances now show "avoid" for contacts 0, 1, 2, 3, 8, 9, 10 and 11.Asked if rep had reviewed various reference electrodes when checking impedances but caller had not.Had rep look through reference electrodes which showed the following(in ohms): ref 0: 1-570, 2-620, 3-640, 8-190, 9-560, 10-620, 11-650 (all showing "avoid"); ref 1: 0-570, 2-490, 3-540.Rep went through the rest of the reference electrodes and didn't see any that were high/around 40k ohms.Caller re-ran impedances and now on ref 15, contacts 2 and 10 were showing green and 0, 1, 8, 9 and 11 were showing as "avoid".Had rep review ref 8 and contact 0 was 190 and the highest was contact 6 at 810 but no contacts were low like contact 0 wa s.Caller re-ran impedances and 0-8 pair was showing as green.Reviewed that pair with low impedance of 190 ohms, may have an issue and to avoid that pair.Reviewed the system may need time to stabilize but caller can attempt programming.Reviewed to check impedances again in a few days or at patient's post-op appointment. no symptoms/patient complications reported.
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Manufacturer Narrative
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Concomitant medical products: product id neu_unknown_lead lot# serial# unknown product type 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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Event Description
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Additional information was received from the rep.It was reported that the cause of the impedance issues was not determined.Actions /interventions were taken were waited until post op to program patient.The impedance issue experienced directly after the surgery had resolved when rep went to program the patient, however hcp had difficulty placing the permanent leads.Which resulted in sub optimal lead placement.Still working on programming with patient.
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Event Description
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Additional information was received.It was reported the difficulty placing leads was due to the patient's anatomy.
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Manufacturer Narrative
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Concomitant medical products: product id neu_unknown_lead lot# serial# unknown product type 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: 977a260, serial# (b)(6), product type: lead; product id: 977a260, serial# (b)(6), product type: 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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