MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Failure to Deliver Energy (1211); Failure to Interrogate (1332); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/17/2024 |
Event Type
malfunction
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Event Description
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Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that patient's representative informed them that patient leaned against something or tripped yesterday, and since then they don't feel any stimulation, and they think that the therapy may have turned off.Agent did not ask about the circumstances that led to the reported issue.Patient tried to connect with implant to check settings but they were not able to locate the implant.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.Due to language barrier, patient's rep asked for "in person" support.
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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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Search Alerts/Recalls
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