MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37601 |
Device Problem
Low Battery (2584)
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Patient Problems
Hypoxia (1918); Dizziness (2194); Therapeutic Response, Decreased (2271)
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Event Type
Injury
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Event Description
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It was reported that the patient had three implantable neurostimulators (ins), one of which was dead.The reporter noted that ¿the batteries implanted a year ago were dead.¿ the reporter was unable to confirm if the two active inss were on or off.The patient had a loss of efficacy unrelated to stimulation therapy; he was experiencing light headedness, dizziness, and hypoxia.These symptoms were believed to be device related and the patient was admitted to the hospital the day prior to the report.The reporter tried to reach out to both physicians involved with the patient, but both were ¿clueless.¿ the patient outcome was not reported, so additional information was requested.If additional information is received, a supplemental report will be sent.Refer to manufacturing reports #3004209178-2015-00006 and 3004209178-2015-00015 for both of the other inss.
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Manufacturer Narrative
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Concomitant medical products: product id: 3387s-40, lot# v813689, implanted: (b)(6) 2012, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.(b)(4).
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Search Alerts/Recalls
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