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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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| Model Number 97800 |
| Device Problems
Break (1069); Electromagnetic Interference (1194); Overheating of Device (1437); Malposition of Device (2616)
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| Patient Problems
Burn(s) (1757); Erythema (1840); Pain (1994); Pocket Erosion (2013); Burning Sensation (2146); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/05/2022 |
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Event Type
Injury
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Event Description
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Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction and fecal incontinence.It was reported that the patient was sedated and in for a mri for their head and neck only, however, after the mri they saw that their ins had burned a hole in their skin.Hcp was on call and removed the battery only.Hcp stated the final area of tissue affected after they operated was around 5 cm.Patient reported they apparently had the device in mri mode.They still have the lead in.Issue was resolved.
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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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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 the patient.They called back and reported that they have no tattoos, they do not have photos of the wound prior to removal but they have several photos following explant that they will email to this case.The patient agreed to return smart programmer.Hcp at mri center reported that guidelines were followed.Mri mode was used, full body eligible seen.Nothing to report during the scan.Following the scan, the patient's mri mode was deactivated and stim was restored and patient went home without incident.Iv medication was used and patient was awake for scan.Brain and c spine scans done <(><<)>1 hour of time on the table with 7 minutes between the two scans.Patient was on their back for the scan.Normal operating mode used.Hcp is going to see if reports/logs can be sent from the scanner.Notes from surgery scheduler included intact lead and general removed and all re moved, confirmed with fluoro.Edges of devascularized and thinning skin noted.Excised until viable tissue reached.Pain noted the day after mri.Patient went to the ed.Dime size hole noted at the ins location and eroding through the skin.Noted as full thickness burn secondary to device interaction with mri.
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Manufacturer Narrative
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Continuation of d10: product id 978b128, lot# va2lavx , explanted: product type lead, b5 has been updated to include information previously captured in 3004209178-2022-14613 as it was determined that this information pertains to this report instead.G3 has been corrected to match aware date of 3004209178-2022-14613.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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that on october 25th patient had an annual mri to check on the status of their ms.The device was put into mri mode and patient was put under conscious sedation so they could remain alert during the mri.Patient did not know what scanning conditions were used to perform the mri.Patent reported the ins area was burned during the mri.It hurt when patient got home and thought it was just from laying on it for an hour and a half during the mri but the next morning there was liquid draining from the ins and at first thought it was a pressure sore but it kept getting worse each day and you could see the device and it was red and swollen.Patient had surgery on friday and the surgeon said they had to remove 3 inches of tissue below the ins.Patient provided the following details from the doctor's op notes: device and leads were removed intact.Malfunctioning or heating occurred, and ins became exposed through a 1 cm area due to skin thinning.Linear incision was made over the ins and incorporated the exposed area through the incision and the ins was dissected out entirely.The wiring was stripped from the lead upon attempt to remove it, a second incision was made to remove the lead intact.Ins and lead both removed and were sent to pathology.They also excised the capsule that encased the ins.Patient reported the wound area is 4.2 by 2.8 by 1.8 and they are currently using a wound vac to improve healing.Patient also plans to follow up with plastic surgery to do further repair.Patient was just discharged from the hospital yesterday.Patient stated their managing urologist had never heard of this happening before.Documented reported event.Recommended patient request that surgeon send explanted device for analysis.The call was disconnected.Ps called the patient back and left a voicemail.
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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 healthcare professional (hcp).The hcp described the injury as circular erythema over the ins and believed that the timing of the patient¿s symptoms with the mri exam was suspicious for a burn.The patient's only predisposing factor for tissue injury was obesity and they did not believe the patient had any history of erosion prior to the mri on (b)(6) 2022.The hcp did take a picture and placed it in the medial tab of the electronic medical record.The hcp removed the ins as well as all of the leads.They did a wide local incision and sent the patient to the wound care team who placed a wound vac to assist with healing.The hcp was not the patient¿s primary urologist but was on call and therefore performed the procedure.Entire device was sent to pathology.Hcp did note that they attempted to separate the leads from the ins, so they are loose, but this did not occur while in use.Hcp has no further information at this time.Additional information was received from a healthcare professional (hcp).The mri safety officer, on (b)(6) 2022, provided types of specific scans that were done related to the head and neck.Head scan was 24 min 24 sec and neck was 15 with 7 minutes between.He will try to get the additional files from the mri equipment that was requested.The pathology lab reported they no longer have the patient's product and it has been disposed of.They reported there is a pathology report that was generated and the hcp would have access to that information.
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Event Description
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Additional information was received from the patient.The patient reported that they had the mri on (b)(6) 2022, and surgery on (b)(6) 2022.The first photo was on (b)(6) 2022 before the wound vac, and the last photo on (b)(6) 2022 when the wound vac was off for 1 week.The wound vac will be applied on their next hcp appointment on thursday.The patient states this has been very difficult; they were in the hospital from (b)(6) and was discharged on (b)(6).They have ms and use an upright walker.They also have urinary incontinence.Carrying this wound vac is a challenge.The wound looked good enough on (b)(6) 2022 for them to take a 20 mental health break for a week.They have an appointment on (b)(6) 2023 with a plastic surgeon.The wound vac is expensive for the patient, and it is hard to reschedule their other appointments to accommodate the wound clinic twice a week.Additional information was received from a healthcare professional (hcp).The hcp reported the medical records from reported event.Following the mri, which was an mri of cervical spine without contrast, the patient was given education, and discharged to home via wheelchair.The patient was able to restart ins before leaving radiology.The imaging report reads that the patient has multiple sclerosis and an mri conditional ins, which was set to mri mode by the patient's daughter, and verified by the mri tech and patient.The patient was scheduled with anesthesia, but the manufacturer advises against general anesthesia so patient can communicate any adverse effects during mri.Vitals post-mri were stable, with no complications documented.
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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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