MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problems
Failure to Interrogate (1332); Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id (b)(4) lot# serial# (b)(6) implanted: explanted: product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: (b)(4).Serial/lot #: (b)(6), ubd: , udi#: (b)(4).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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Event Description
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Information was received from a patient (pt) regarding their recharger (insr). they reported that earlier in 2024 they started seeing a caution message stating the recharger was warm and hot, but it hadn't happened since then. then, on (b)(6) 2024, they noticed that the insr was not recharging the implanted neurostimulator (ins) in their belly.The pt had the recharger on for 4.5 hours and it did not charge the ins battery.The pt said they never had it on top of the clothing for they thought that could stop the charge going through. also when they go to use the programmer they kept getting "charge ins' message even after they put new batteries in the programmer.Pt had maybe 24 hours of peace when it did this and now their hand was killing them. no symptoms were reported against the recharger. during call pt verified no damage to the insr antenna.Pt attempted to recharge the ins and all 8 coupling boxes filled in.Earlier there were no coupling boxes.The troubleshooting steps that were taken on the call resolved the issue. .
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