MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37602 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Complaint, Ill-Defined (2331); Dyskinesia (2363)
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Event Date 03/25/2015 |
Event Type
Injury
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Event Description
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It was reported the patient went to the hospital for unknown reasons and was experiencing parkinson¿s symptoms and dyskinesia.The manufacturing representative did not know if the patient¿s medication had been adjusted.On (b)(6) 2015, the patient went into cardiac arrest and had been resuscitated.The manufacturing representative had gone to the hospital and checked the patient¿s device.Everything was found to be in normal working order and all impedances were in normal range.At the request of the patient¿s healthcare professional (hcp), stimulation was turned down from 3.8 to 2.5v.The patient had been intubated, was unable to communicate, and remained in the intensive care unit.The patient had their implantable neurostimulator (ins) replaced on (b)(6) 2015.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_lead, product type lead.Product id: neu_unknown_prog, product type: programmer, physician.(b)(6).
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Search Alerts/Recalls
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