MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
High impedance (1291); Overheating of Device (1437)
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Patient Problems
Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Burning Sensation (2146); Discomfort (2330)
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Event Date 12/02/2019 |
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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The consumer reported that since implant he had pain all around the implant site and incision.The patient stated that the site was very tender to the touch and caused much discomfort.When charging the implant the patient had to put the recharger to the implant which was very uncomfortable.The patient didn¿t think the area was swollen and it was not hot to the touch, but it was tender so that he can¿t even lay on it when sleeping.The patient mentioned he had gained some weight since implant and thought that could be the reason the incision felt like it was pulling, but noted the incision had healed all the way.The patient was directed to follow-up with their healthcare provider.Additional information was received from the patient via a manufacturer representative.It was reported that there was a burning/stabbing pain at the ins site.The skin looked like it was scarring from continual heated charging.Bleeding was also reported.The patient said this has been happeneing since implant, but ut has gotten worse with the time.Impedances were within normal range except for 0 which was high and reported prior to the new implant placement.There was talk of replacing the battery to a non-rechargeabledevice to combat the burning pain during recharge.
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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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It was reported that the infection has been resolved.
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Event Description
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Additional information was reported that the rep discussed options for the patient, and it was decided that they would switch to a n on-rechargeable battery.On august 26th the pocket was opened and it was determined that the patient had a low grade infection.All of the patient's equipment was explanted.
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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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