MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 7428 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Impedance Problem (2950)
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Patient Problem
Electric Shock (2554)
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Event Type
Injury
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Event Description
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It was reported the patient was having shocks and there was a question of some malfunction of the implantable neurostimulator (ins) when the patient met with their healthcare professional (hcp) on (b)(6) 2010.The patient¿s right side was programmed to 5-, 6-, 7+ at 4v, 90 usec, and 185 hz and their left side was programmed to 1-, 3+ at 3.8v, 90 usec, and 185 hz.There was a question of an intermittent circuit problem.The hcp felt the ins should be replaced.After the ins was replaced, impedances were all measured to be normal and the ins was programmed using the patient¿s old settings.
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Manufacturer Narrative
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Concomitant medical products: product id: 3387s-40, lot# v101646, implanted: (b)(6) 2008, product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 3387s-40, lot# v108523, implanted: (b)(6) 2008,product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.(b)(4).
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Search Alerts/Recalls
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