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); Pocket Stimulation (1463); Unstable (1667)
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Patient Problems
Undesired Nerve Stimulation (1980); Pain (1994)
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Event Date 12/22/2023 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence.It was reported that the patient had ipg site pain since about christmas time. patient stated they experienced sporadic uncomfortable electrical stimulation at the ipg pocket site. patient underwent ipg repositioning at original pocket site.It was determined that an impedance check came back normal but the ipg migrated to an improper angle in pocket with edge of device protruding toward patient skin.Surgeon revised pocket and repositioned ipg in to correct position within the pocket. additional information was received from the patient.They reported that the rep spoke with them on 2024-apr-12.Patient stated the ipg site issues and symptoms have been resolved since ipg repositioning on 2024-apr-02.
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Manufacturer Narrative
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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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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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