MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Failure to Power Up (1476); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190); Data Problem (3196)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
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Event Date 01/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 97745, serial#: unknown, product type: programmer, patient.Other relevant device(s) are: product id: 97745, 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 consumer concerning patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported the controller screen displayed a ¿system problem¿ message.The patient stated the message occurred when she was using the controller, no recharger or power cord, and was just attempting to connect the controller with the ins.The patient stated the controller eventually powered off and would not power back on.The patient stated she felt the stimulation turn off yesterday because she was not able to charge the ins and.It made sense that the battery level got too low so she felt it turn off.The patient connected the controller to the power cord and confirmed the screen powered on.The patient stated the controller displayed the memory problem screen.It was reviewed how to use the controller to adjust the date/time and patient stated she messed it up and had bypassed the screens.The patient stated she was then on a screen stating that the controller needed to be charged and the controller was not attached to the power cord.The patient plugged int eh power cord and confirmed the green light was blinking at the top of the controller.The controller was stating that the stimulation was off, and the stimulator needed to be charged.The patient was advised to charge the controller then connect the recharger and charge the ins.It was reviewed the date/time can be corrected by accessing the date/time via the menu.It was recommended that the patient call back after the controller is charged if she needs assistance.No further complications were reported/anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Patient provided their weight information and the serial number of the ins.Patient did not remember what the error message said but was something about "controller no longer working".Steps to resolve were patient plugged the controller into the wall to charge, then attached to the waist belt to charge the battery in their back.The issue was resolved and there were no problems since.Patient did not notify their physician.No further complications were reported.
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Search Alerts/Recalls
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