MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97714 |
Device Problems
Failure to Interrogate (1332); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Burning Sensation (2146); Electric Shock (2554); Alteration In Body Temperature (2682); Alteration in Body Temperature (4568); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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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 consumer via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins).The patient reported warmth with charging since the device was implanted.The patient stopped using the device in may due to ¿zapping".She had not charged since may.No factors were known to have led or contributed to the issue.The rep was unable to read the device.The doctor was planning to replace the ins battery, but surgery was not yet scheduled.The rep would be present for replacement.The issue was not resolved.
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Event Description
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Additional information was received from the manufacturer representative (rep).The cause of the warmth with charging or zapping was not determined.The warmth was noted at the site where the patient was charging.Battery replacement had not been scheduled.
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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 manufacturer representative regarding the patient on (b)(6) 2020.It was reported that the entire system was replaced on (b)(6) 2020.
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Manufacturer Narrative
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Continuation of d11: product id 3550-29 lot# n720910 serial# implanted: (b)(6) 2017 explanted: (b)(6) 2020 product type accessory pr oduct id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2017 explanted: (b)(6) 2020 product type lead.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.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: analysis of pli# 10 product id# 97714 found stim ins/battery/overdischarged and permanently damaged.Analysis of product id: 977a260, serial# (b)(6), implanted: (b)(6) 2017, explanted: (b)(6) 2020, product type: lead.Found stim lead/body/conductor/broken/at injex anchor site.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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