MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 7428 |
Device Problems
Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dysphasia (2195); Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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It was reported that the patient was first implanted in 2008 and the caller stated everything was fine, but as time went on, the patient was less and less able to speak, and had difficulty making specific mouth movements with their lips and tongue.The caller stated that this speech issue was due to the electrode being too close to the "speech capital" of the patient's brain, and that electricity leads over into the "speech capital." the caller mentioned that when the dbs was turned off, the patient could speak clearly but then their tremors would return, and the caller referred to these as "violent tremors." thus, they decided it was best to keep therapy turned on to help manage the tremors.Caller mentioned that the patient has a local parkinson's support group that they are involved with and they suggested that medtronic develops a public forum for patients so they can share their experiences.The caller was wanting to share the patient's negative experience.Pss reviewed that the event in the other call code note would be reported and will have visibility downstream.
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Manufacturer Narrative
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Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 21-feb-2011, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: 21-feb-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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