MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Failure to Interrogate (1332); Overheating of Device (1437); Failure to Power Up (1476); Battery Problem (2885); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996)
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Patient Problems
Burn(s) (1757); Erythema (1840); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4).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 who was implanted with an implantable neurostimulator (ins).The reason for call was patient (pt) reported their controller was completely "dead" and unresponsive.Pt stated they couldn't get it to power on at all.Patient services (ps) walked caller through removing the battery pack and plugging controller into the ac power cord; caller confirmed controller powers on.Caller inserted the battery pack, then connected the recharger and attempted to initiate a charge session.Caller confirmed "no device found" continued to display.Pt also commented that a manufacturer representative (rep) instructed pt to place a sock over the recharger paddle because it became so warm that it left a red mark/"burn" on pt's skin.Ps attempted to confirm if the recharger paddle seemed abnormally warm and pt said no.However, did refer to the mark the paddle left as a burn.The patient was sent a replacement recharger (rtm).
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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 a patient (pt) who was implanted with an implantable neurostimulator (ins).The patient stated that the issue has been resolved.
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Manufacturer Narrative
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H3: product id 97755, serial# (b)(6), was returned for product analysis.Analysis found that the complaint was unable to be verified.They found no issues with finding or charging the ins.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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Concomitant medical products: product id 97745, lot#/serial# (b)(6), product type programmer, patient product id 97755 ,lot#/serial# (b)(6), product type recharger h3.Analysis was performed on [serial/lot #: (b)(6)] analysis found that the complaint was unverified.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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