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); Communication or Transmission Problem (2896)
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Patient Problem
Burn(s) (1757)
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Event Date 10/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 97755 ,serial# (b)(4).Other relevant device(s) are: product id: 97755, serial/lot #: (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 (pt) regarding an external device.It was reported that when they try to recharge their implantable neurostimulator (ins), they cannot find the device and in passive recharge mode it displays all zeros.Pt said the last time they charged, the recharger telemetry module (rtm) got really hot and burnt their skin.An email was sent to the repair department to replace the rtm.Pt mentioned that when they try to turn their ins on now, their controller displays no device found.Patient services (pss) reviewed that once they receive the rtm replacement, they should be able to recharge the ins and then should be able to connect as intended with their controller.
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Event Description
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Additional information was received from a patient regarding an external device.The patient stated that the issue was resolved with the replacement of the 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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Manufacturer Narrative
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H3: product id: 97755, serial# (b)(6), was returned for product analysis.Analysis found there was a recharger antenna failure; they were unable to test if the device got hot due to it immediately going into a "no device found" error.Also, the recharger antenna had insulation that was being pulled out of the donut.The device was scrapped after failing at plexus and bench testing.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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