MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Wound Dehiscence (1154)
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Event Date 04/18/2024 |
Event Type
malfunction
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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 unknown indications for use.It was reported that they had their husband look at the incision site where the device was implanted last night ((b)(6) 2024), and they noted the steri-strip had already fallen off a couple of days ago, but last night, when their husband looked at the site, they could see the ins through the incision.The patient stated they couldn't see the incision site themselves because it was on their booty; however, they stated their spouse said it didn't look infected.They had a picture of it where you could see it but when they moved, you couldn't see the ins.The patient stated they called their health care provider (hcp) office first thing this morning and spoke with someone who said they would "send a message" about it, but they still hadn't heard from the hcp, so they thought they'd call patient services instead because they didn't know what to do and they didn't have the number of the local medtronic representative (rep) to call.Patient services reviewed the role of the rep with the patient and redirected the patient to continue trying to contact their health care provider (hcp).Patient services also sent an email to the mdt rep to alert them of the situation. patient services again redirected the patient to follow up with their hcp.Patient stated they would.Documented the reported event.No further action was taken by patient services.
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed valid.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received from the patient.They reported that they contacted their hcp about the issue on (b)(6) 2024.When asked about the cause of the ability to see the ins through the incision they stated that it was not determined but that the steri-strip fell off too soon.When asked what steps would be taken to resole the issue they stated that they put a tegaderm over the site that was opened and saw the hcp on the (b)(6).The issue was resolved.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received from the patient.They stated their device got infected and the site never healed properly and they could see the device coming out of their skin.Patient stated they were on antibiotics due to the infection.Patient reported they had their implant removed on (b)(6) and they have a follow up appointment on june 10th.Their indications for use were urge incontinence and urinary/bowel dysfunction.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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