MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37601 |
Device Problem
Electromagnetic Interference (1194)
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Patient Problems
Discomfort (2330); Complaint, Ill-Defined (2331)
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Event Type
malfunction
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Manufacturer Narrative
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The event date is unknown 8-9 years ago.Other relevant device(s) are: product id: 3389s-28, serial/lot #: (b)(4), ubd: 11-may-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported the patient had a terrible time when they had their left brain implants.The right was done while sedated.The left mri was done while "awake".The patient was unable to tolerate the second mri.It took days for the patient to summon the ability.That was 8-9 years ago.
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Event Description
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Additional information received from the consumer reported ¿there was a little confusion regarding the patient¿s second surgery which was done via the traditional methods (frame while semi-sedated).He tolerated the surgery without major issues other than complaints of soreness to his neck, which always gave him problems.Following the second surgery (the one to his left hemisphere) he needed to have an mri done to make sure placement before he left the hospital.It took several tries through the following days as each time resulted in panic and anxiety while going for this follow-up mri.It was at the end of the 4th or 5th day that i suggested that they allow him to have his head elevated while being wheeled to the mri room which helped a bit, so they were able to get the mri done successfully.¿ in addition, ¿my husband¿s problems do not seem to be related to the device itself.They are psychological issues which seem to prevail today but have been helped by medications.No further complications were anticipated.
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Search Alerts/Recalls
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