MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Electric Shock (2554)
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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 urinary/bowel dysfunction and urge incontinence.It was reported that the ins has moved and is sending shocks down the leg.The caller reports that they have lost a lot of weight and that is why the ins moved.The caller asked if there is a way to remotely turn the therapy off because the shocks are not comfortable.Reviewed no.The caller does not have a healthcare provider (hcp), but are trying to see one tomorrow.When asked, the caller did not say when it began, only that is has gotten worse over the past month and a half.They have turned the therapy way down.The patient was redirected to their healthcare provider to further address the issue.
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Manufacturer Narrative
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B3: event date is not known.Please see b5 for approximate date range, if applicable.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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Search Alerts/Recalls
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