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); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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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Event Description
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Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was caller reported that their 'battery went bad' and wouldn't take a charge.The caller stated that when they plugged the controller into the ac power supply, the green light would come on and flash, but the controller wouldn't send the charge over again.Patient stated that they saw no device found on the controller, so patient service specialist walked the caller through entering passive recharge mode and pt saw connectivity strength of 92.A few minutes later progressed to charging normally.The controller was at 100% and the implant was at 30%, recharging excellent.The troubleshooting steps that were taken on the call resolved the issue.Pt mentioned they had misplaced the controller for a while and when they found it, showed no device found.
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Search Alerts/Recalls
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