MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37601 |
Device Problems
Ambient Noise Problem (2877); Electromagnetic Compatibility Problem (2927)
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Patient Problems
Fall (1848); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Dyskinesia (2363); Ambulation Difficulties (2544); Cognitive Changes (2551)
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Event Type
Injury
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Event Description
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It was reported that the patient had 10 ultra sound treatments beforehand and 2 weeks ago had 6 procedures.It was noted that the patient had a loss of therapeutic effect.It was noted that the reporter stated that with all the patient¿s medications the patient lost their balance all the time and fell frequently.It was noted that when the patient fell they did not hit their head and fell on their elbow and broke it.It was noted that the patient also had experienced changes in mental cognitive abilities.It was noted that again it was worse.It was noted that the patient had uncontrollable movements, and made spontaneous drastic movements, with their hands and sometimes hit the wall for furniture.It was noted that the patient had gone to the health care professional (hcp) and was referred for physical therapy.It was noted that the hcp was checking the device.Additional information received reported that the patient recently had an ultrasound and was not feeling well.It was noted that the ultrasound was five days ago and the patient had a convulsion like epilepsy and was shaking.It was noted that the patient had an ultrasound because of the parkinson¿s.It was noted that the patient had hit their elbow and the elbow had a bump so the patient was referred for ultrasound.It was noted that it was therapeutic ultra sound.It was noted that patient had had this before when the weather was changing and was thinking it was maybe the ultrasound procedure.Additional information has been requested, but it was not available as of the date of this report.
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Event Description
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Additional information received reported the patient had fractured their thumb and they needed an x-ray.It was noted the patient had unruly movement and they would hit walls, stairs, all over, and they would have frequent falls.It was stated the patient had damaged their ¿stump¿ and their elbow and as a result they had bursitis in their elbow.It was noted the patient had gotten a therapeutic ultrasound one and a half months prior to report for the bursitis.It was noted it was the size of a lemon and the condition had begun a year prior to report.It was stated the patient had convulsed with the ultrasound treatment and it stopped when the treatment stopped.It was noted the patient status was unknown and their deep brain stimulator (dbs) was under observation by the patient¿s doctor.
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Manufacturer Narrative
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Concomitant medical products: product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 3387s-40, lot# v499735, implanted: (b)(6) 2010, product type: lead.Product id: 3387s-40, lot# v460686, implanted: (b)(6) 2010, product type: lead.(b)(4).
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