MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problems
Migration or Expulsion of Device (1395); Overheating of Device (1437)
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Patient Problems
Burning Sensation (2146); Discomfort (2330); Malaise (2359); Weight Changes (2607)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 37751,serial# (b)(4), product type recharger.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 manufacturer's representative (rep) via a patient regarding the patient's recharging system. it was explained that when the recharger was plugged into the wall and the implanted neurostimulator (ins) was being charged, the entire recharging system (including antenna) would get warm and this has been happening for "months".Patient would unplug the recharger from the wall and notice it's warm and then have to let it cool down.Caller stated that patient charges once a week and it typically takes them 4 hours (starting at maybe 30%) despite having full coupling bars for the most part.Caller stated that patient hasn't seen any error codes or messages on the screen and recharging system was in good condition when caller examined it yesterday at patient's reprogramming appointment.Caller didn't check recharging stats from tablet when meeting with patient yesterday.The caller was not with the patient.The caller was redirected to have patient continue to charge normally over the next few weeks and then meet with patient again to review recharging stats.It was reviewed that recharger is an electronic device so it may get somewhat warm during use and the 4 hour average charge time isn't out of the ordinary if coupling is changing and ins is low.It was reviewed recharger may need to be replaced but to simply monitor the issue at this point and check recharging stats first. the manufacturer representative reported that the burning sensation is uncomfortable.The date of the appointment when the recharging stats were obtained and reviewed was (b)(6) 2021.The recharging stats did not help to identify why recharging is taking 4 hours to complete.The patient is waiting for approval for replacement of the recharging system.Additional information was received.It was reported that for about 2 months when the patient attempted to charge their ins the implant would get hot then the recharger would get hot.When the patient charged the implant it burned.A new recharger was requested.
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Manufacturer Narrative
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Continuation of d10: product id: 37751, 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 was received and it was reported that the patient would be seeing their healthcare provider, on (b)(6) 2021, to have a fluoroscope done to see if all is connected (wires and such).The issue had not been resolved as they were waiting to see what the results of the fluoroscope were.Their unit was off for 3 weeks.It had not changed in any aspect and continues to home the burn, which was very uncomfortable on a daily basis.
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Manufacturer Narrative
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Continuation of d10: product id 37751 lot# serial# (b)(6) implanted: explanted: 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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Manufacturer Narrative
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Concomitant medical products: product id: 37751, 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 was received.It was reported, that since (b)(6), they have been losing weight, unhealthy being always sick.Steps taken include being seen by the doctor for fluoroscope.They believe that with the weight loss, the battery was so close to their nerves.So they thinks having the system replaced is the best way to go.It moves back and forth in the pocket as well.Alas, they believe having it moved to a different spot would help as well.
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Search Alerts/Recalls
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