MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Overheating of Device (1437); Charging Problem (2892); Connection Problem (2900)
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Patient Problem
Burn(s) (1757)
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Event Date 10/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 97755, serial# (b)(4).Product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot # :(b)(4), udi#: (b)(4).
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Event Description
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Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).The patient reported that where the circle part and cord are connected on the recharger (rtm) gets warm and now it¿s getting very hot and burning her skin and she put a shirt between her skin and paddle or she stop charging.Patient states the rtm is not charging her implant either.Patient services confirmed burning did not damage the skin.
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Event Description
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Additional information received reported that the circumstances were unknown but the wires may have shorted out.
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Manufacturer Narrative
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Concomitant medical products: 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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See h10.
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Manufacturer Narrative
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H3: product id 97755, serial# (b)(6), was returned for analysis.Analysis of the device found that there was a recharger telemetry module (rtm) failure, the 'no device found' message was seen and 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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