MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 97800 |
Device Problems
Overheating of Device (1437); Malposition of Device (2616)
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Patient Problems
Burn(s) (1757); Erythema (1840); Unspecified Infection (1930); Pain (1994); Discomfort (2330); Insufficient Information (4580)
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Event Date 08/22/2022 |
Event Type
Injury
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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 the patient's first device was removed due to infection.The patient said their first implant got infected and had to be removed.The implant was superficial and they could feel a square on their hip and it was really sore.It didn't feel like it was healing.It felt like altoids box under their skin.It was hard.They had random burning type pains.Sore to touch.They could see "red line vertical line" and it is still there. the patient was prescribed antibiotics.It went on for 5-6 weeks before the stimulator had to come on.The patient stated the symptoms started pretty early on; their first follow up was around the holiday labor day and it was already sore and not feeling right.No further action was taken by patient services.The patients current implant is lower and they can't feel it all.This one feels right where the other one never did.
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Manufacturer Narrative
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Date of event.Date is estimated; year is valid.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 healthcare professional (hcp): when asked to clarify whether the signs and symptoms reported at the time of infection ("random burning type pains" and the presence of a "red line vertical line") were associated with the infection or whether there were other issues reported with the implantable system, the hcp responded: pain to incision, redness, minimal impact with oral antibiotics., and that the burning type pains and presence of a red line had resolved.
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