MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Overheating of Device (1437); Charging Problem (2892); Connection Problem (2900); Insufficient Information (3190)
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Patient Problem
Burn(s) (1757)
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Event Date 09/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of concomitant products: product id 97755 lot# serial# (b)(4) implanted: unk.Explanted: unk.Product type: recharger.Information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), ubd: , udi#: (b)(4) event date: date is approximate.
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Event Description
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Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that for the last few days the recharger (rtm) started to have exposed wiring and now while attempting to charge the implant the rtm burns them.The pt was no longer able to charge their implant.Pt had also received a message of cannot charge and to contact the manufacturer.An email was sent to the repair department to replace the recharger.
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Manufacturer Narrative
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Continuation of d10: product id 97755 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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Event Description
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Additional information received from the patient.It was reported that the burning recharger issue was resolved.
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Manufacturer Narrative
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Continuation of d10: product id 97755, serial# (b)(6), product type recharger h3.Analysis found the recharge antenna insulation was torn.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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