MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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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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 patient said they were having difficulty to get the communicator to connect to their stimulator.Patient said it took 3- 4 attempts to get it to recognize it pt wondered if some equipment should be replaced.Worked with patient to synch the handset and communicator and patient was successful to connect.Pt said they apply pressure because they've gained 40-50 lbs. reviewed best practices for communicator placement and patient confirmed they were able to successfully connect again.The troubleshooting steps that were taken on the call resolved the issue.The patient mentioned when they first got the stimulator, they were slimmer than they were now they are maybe 40 50 pounds heavier and when their first implant was replaced they they noticed about a week later: it felt closer to the skin than the first one they had, they think the weight pushes it closer to the skin than the first one was. see related pe (b)(4), could not get it to function (b)(4): mva/ broken ins/replaced.
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Search Alerts/Recalls
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