MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Use of Incorrect Control/Treatment Settings (1126); High impedance (1291); Overheating of Device (1437); Human-Device Interface Problem (2949)
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Patient Problems
Burning Sensation (2146); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2021 |
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 patient via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins).It was reported that during the implant there was out of regulation (oor) electrode 0, 4, 14 when connectivity was confirmed with tablet at surgery.Leads were retracted, wiped reinserted.Same.Decision with healthcare provider (hcp) made to see what was revealed postop.Electrodes 4, 14 resolved, but 0 remained.Decision made with hcp to continue program around if continues at post op appt.Heating at ins site after programming.No external factors were noted that may have led to the impedance issue. patient did note a fall which delayed her post op appt.Had large knee contusion. impedance reread, flipping patient postop, resolved 2/3 electrodes 1/19 and waiting to see if last electrode resolved at post op appointment.On (b)(6) 2021, patient was seen and programmed per protocol.Oor #1 remained.Patient¿s leads seemed to be reversed in ins and therefore flipped in tablet, which led to some confusion when talking with study coordinator, field technical advisor, patient and hcp, and 0 electrode inadvertently used. patient was instructed to use program on other channel and heating at pocket resolved.Patient will be seen again on (b)(6) and reprogrammed, per protocol without using 0 electrode.The issue did not resolve. no 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.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 received from the manufacturer representative reported that the cause of the leads seeming to be reversed in the implant was either a procedure issue with what leads were in which channels or a communication issue between the representative and the doctor.The issues had been resolved.
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Event Description
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Additional information was received.It was reported that impedances were high and out of range >20,000 ohms on electrode 0.
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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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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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Patient states that stinging in battery site has returned.She will be seen and evaluated on monday.
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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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Additional information was received from the manufacturer representative (rep) reporting that the stinging at the battery site seems to have resolved.The cause of the stinging at the battery site was unknown.It was reported that they shifted from one group to another and back.It was indicated that no further reports of the stinging had been noted.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.
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Search Alerts/Recalls
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