MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97810 |
Device Problems
Unstable (1667); Malposition of Device (2616); Charging Problem (2892)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 fecal incontinence and urina ry/bowel dysfunction.It was reported that probably like a year after they were implanted, they'd been having trouble getting their ins charged for a while so they stopped using it but now they were using it again and they wanted to know if they were supposed to have cellular connection with their programmer.The patient stated they'd just noticed a circle with a slash on it that they'd never noticed before.Patient services reviewed external device function with the patient and the patient further elaborated why they stopped using the therapy for awhile: patient stated they didn't know if it (the ins) shifted, but that the ins was on an angle under their skin so they had to be bent over in half to get the recharger to connect to charge the ins.Patient services asked the patient if they'd had a fall or trauma that led to the issue and the patient stated no.Patient stated the issue was just that the ins didn't seem like it was parallel with their skin anymore and that the top of it was almost poking through the skin (though they clarified it was not poking through the skin, it just was very prominent under the skin).The caller stated they didn't think it was supposed to be like that.Patient services redirected the patient to follow up with their health care provider (hcp) to check the implanted system and the patient stated they were going to reach out to their managing health care provider about the issue.
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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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