MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97714 |
Device Problems
Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Electric Shock (2554)
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Event Date 02/01/2018 |
Event Type
Injury
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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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Information was received from a patient implanted for non-malignant pain.The patient reported that their device periodically gives them a spasm, where their entire body will jump.They stated that they would like to coordinate an appointment with a manufacturing representative.The patient noted that they currently have their stimulation turned down very low.Patient services reviewed the options of lowering stimulation or turning it off until the unit can be checked, and to also turn off adaptive stimulation.The patient stated that they notice the issue more when laying down, but otherwise experience it in most positions.Patient services sent communication out to the field.The patient was re-directed to their healthcare provider.No further complications were reported or 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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Additional information was received from the consumer on 2019-jun-10 reporting that there was no change in personal activity or no visible underlying cause to the event.It was still giving the same shocking sensation since (b)(6) 2018.There was a change in programming, a conductivity test, impact test and x-ray for visual inspection performed for troubleshooting.The issue was still unresolved.The patient was still getting periods of unconsciousness after shocks.No further complications were reported.
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Search Alerts/Recalls
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