MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number 37612 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Burn(s) (1757); Discomfort (2330)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 37651, serial# (b)(4), product type: recharger.Other relevant device(s) are: product id: 37651, serial/lot #: (b)(4), udi#: (b)(4).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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It was reported that "back in at least 2019" the patient got a red burn mark over the implant site from having the recharger antenna over the implantable neurostimulator (ins) for a long period of time.The patient confirmed that the external equipment did not cause them any harm.The patient noted that the red burn mark was uncomfortable, but it did not blister or leave a scar.The patient likened the red burn mark to a "moderate sunburn." the patient also noted that the recharger antenna was not against bare skin when this happened, and that they were wearing a thin shirt.The patient stated that they ended up splitting their ins recharge sessions into 2 nights (as opposed to 1 night) so they would not need to have the recharger antenna over the implant site for as long.The patient confirmed that they no longer had the red burn mark after adjusting the schedule for their ins recharge sessions.
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Manufacturer Narrative
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Concomitant medical products: product id 37651 lot#/serial# (b)(6), product type recharger 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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Search Alerts/Recalls
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