MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); High impedance (1291); Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
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Patient Problem
Pain (1994)
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Event Date 04/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 3487a-33, lot#: unknown, product type: lead.Product id: 3487a-33, lot# :unknown.Product type: lead.Other relevant device(s) are: product id: 3487a-33, serial/lot #: unknown.Product id: 3487a-33, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient felt a slight heavier current than usual while changing position.Symptoms of chronic pain were returning slowly as the effectiveness of the stimulation was not given anymore which was a sudden change.No event occurred that contributed to the event, the patient was very fit and sporty.Troubleshooting was performed.The doctor performed a ¿radioscan¿.The scan showed that the leads moved and were not in the post-surgical positions anymore.Stimulation through other electrodes were not possible anymore.Impendences were bad, especially on electrodes 0 (40,000) and 2 (17,000-21,000).A surgical replacement of both leads was planned.The issue was not resolved at the time of this report.The patient was alive with no injury.
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Search Alerts/Recalls
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