MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37612 |
Device Problems
Battery Problem (2885); Device Operates Differently Than Expected (2913)
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Patient Problems
Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515); Ambulation Difficulties (2544)
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Event Date 06/30/2018 |
Event Type
malfunction
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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 by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for parkinson's dual, movement disorders.It was reported that the patient's battery discharged.Their symptoms returned, which were tremor rigidity and bradykinesia.The rep then interrogated with the device, recharged it, and turned the device on.The issues were resolved.There were no further complications reported.
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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: it was reported that the cause of the patient's battery discharging was user error.The patient's weight was asked but unknown.There were no further complications reported.
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Search Alerts/Recalls
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