MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37602 |
Device Problem
High impedance (1291)
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Patient Problem
Cognitive Changes (2551)
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Event Date 03/17/2015 |
Event Type
Injury
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Event Description
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It was reported the patient was admitted to this hospital for a mental change and a kidney infection.The patient¿s healthcare professional (hcp) wanted a manufacturing representative to check to make sure the device was still functioning properly.The implantable neurostimulator (ins) was programmed on the left to 0-, 3+ at 4.8v, 60 us, and 160 hz.Therapy impedance on the left side was measured to be 2638 ohms.Impedances on the left side, run at 1.5v, were measured to be high with impedance of 2773 ohms being measured on electrode pair c-0.The left ins battery voltage was measured to be 2.98v.The right ins was programmed to 1-, 3+ at 4.5v, 60 us, and 180 hz.Therapy impedance on the right side was measured to be 2538 ohms.Impedances on the right side, run at 3v, were measured to be high on electrodes c-0, c-3, and 0-3.The right ins battery voltage was measured to be 2.87v.No interventions or outcome were 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: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3389-40, lot# j0406024v, implanted: (b)(6) 2004, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.(b)(4).
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Event Description
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Additional information received reported the implantable neurostimulator (ins) was checked by a manufacturing representative while the patient is in a hospital to make sure it was working.No problems were found with the ins and the healthcare professional's goal was to rule out a deep brain stimulation problem as a cause of the patient's decline.No actions were taken and the issue was not device related.
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