MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 12/08/2014 |
Event Type
malfunction
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Event Description
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It was reported the patient had no stimulation sensation starting the night prior to call.While on the call, the patient was able to increase stimulation.The patient could feel stimulation afterwards.
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Manufacturer Narrative
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Concomitant medical products: product id: 3889-28, lot# va0pc4h, implanted: (b)(6) 2014, product type: lead.Product id: 3037, serial# (b)(4), product type: programmer, patient.(b)(4).
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