MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Unstable (1667); Communication or Transmission Problem (2896); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
Event Type
Injury
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient was unable to connect recharger to the ins.The battery flipped sideways so can¿t connect to charger.Positioning patient different and confirmed ins position via fluoroscopy imaging.It was noted that the physician did not make lower half of pocket deep enough. ins fell into pseudo pocket.The ins was also tilted, which contributed to the inability to communicate. the patient is scheduled for a device revision.The pocket was revised with success and the issue was resolved.The manufacturer representative (rep) indicated they would send any further information as they become aware.
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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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