MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97716 |
Device Problems
Low impedance (2285); Patient Device Interaction Problem (4001)
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Patient Problem
Pain (1994)
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Event Date 06/01/2022 |
Event Type
malfunction
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Event Description
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On (b)(6) 2022 , rtg0311248 (con, rep): information was received from a manufacturer's representative (rep) regarding an implantable ne urostimulator (ins). the rep reported that the patient hit the battery and they think that they may have pulled the lead wires down a little bit.The patient was having really bad pain after they hit the battery.The caller reported that the hcp wass doing an xray at the time of the call.The rep reported that four electrodes were showing the avoid indicator, 6 7 14 and 15 with the following values from the impedance test on the tablet: ref 4: electrode 6 240 ohms all other pairs 650-800ohmsref 7: 15 240ohms troubleshooting was not required.The issue was not resolved through troubleshooting.Tss reviewed information about impedances.The caller will follow-up with the patient and hcp.
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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.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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Upon further review: in the case technical services entered a typo in the original note, the call code note reads "ref 4: electrode 6 240ohms all other pairs 650-800ohms" this should have said ref 14: electrode 6 240ohms all other pairs 650-800ohms.The low impedance was associated with pair 6 and 14.Correction applied to event.
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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.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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Rep reported that an x-ray was done to confirm there was no change in lead placement.No changes were seen on x-ray.A connectivity test was performed to ensure proper placement of leads into ins.Everything was "green" and working appropriately.Impedance test run to ensure there was not a "break" in the wires.The low impedances were likely due to close proximity of those specific electrodes on the wires.Therapy it self was not effected.No changes were made the patients programming.
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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.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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