MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 97715, serial# (b)(4), implanted: (b)(6) 2018, product type implantable neurostimulator.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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for other pain indications - other.It was reported that the patient will be getting 2 ins replacements today, and possible lead revision, for unknown reasons.Caller has not met with the patient yet.Additional information was received from the manufacturer representative (rep).It was reported that the patient was having pocket revisions to make the implants more comfortable.The surgeon decided to replace both ins in the process as well.The leads were working and did not require a revision.The issue is resolved.The rep has no further information.
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Search Alerts/Recalls
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