Model Number 37800 |
Device Problems
Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Erosion (1750); Pocket Erosion (2013); Electric Shock (2554); Unspecified Tissue Injury (4559)
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Event Date 07/15/2022 |
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 gastrointestinal/ pelvic floor.It was reported that patient saw dr.On july 15th, the battery was coming out through the skin.Hcp packed the wound and wanted to put the device into an ostomy bag.Caller inquired how hcp should care for the wound.Technical services(ts) reviewed with caller that hcp normally would explant the neurostimulator at this point due to infection concerns, however, it's up to hcp to address this issue medically.Troubleshooting was not required.The issue was not resolved through troubleshooting.
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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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B3: event date is estimated upon review the serial number of the affected device is unknown.Report updated to reflect this information.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 battery coming out through the skin was described by the doctor as the pacemaker was rotating and pushing upward.The device has also been off because it had been shocking the patient.Symptoms have not worsened since its been off.Impedance check was done and everything was normal.Ins was left off.They further described issues going on with the ins.The current ins has eroded through the abdominal wall.The patient indicated they do have some metal allergies and certain earrings give them trouble, although they have never been test for a metal allergy.They wonder if this is more of an allergic reaction to the ins.They externalized the ins completely and placed it in an ostomy bag.
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Event Description
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Additional information was received from a healthcare professional (hcp).The hcp reported that replacement was scheduled for (b)(6) 2023.
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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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Search Alerts/Recalls
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