MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 7426 |
Device Problems
Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); High impedance (1291); Energy Output Problem (1431)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from the healthcare professional via the manufacturer¿s representative regarding a patient with an implantable neurostimulator (ins) for parkinson¿s disease.It was reported that when the right ins was interrogated (had bilateral devices) on (b)(6) 2017 and was at 3.6.It was noted that the ins was in the abdomen and goes to the right brain.It was noted that the impedances were >2000 ohms on all connections.The patient felt ¿it comes off and on all the time¿.The right ins programming was done on the right subthalamic nucleus (stn) only, helping their mild tremoron the left side.Additional follow up programming was also performed on (b)(6) 2016, (b)(6) 2017, and (b)(6) 2017.Further, it was reported that on battery was replaced the week prior to (b)(6) 2017.Relevant medical history included parkinson¿s disease, idiopathic peripheral neuropathy, arachnoiditis, left foot drop which was related to the l5 radiculopathy.The patient also had a pump for pain.There were no further complications reported or anticipated.
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Manufacturer Narrative
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Additional concomitant medical products: product id 7426, (b)(4), product type implantable neurostimulator.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Analysis of the implantable neurostimulator (ins) ((b)(4)) revealed that the battery was functioning okay with insignificant anomaly¿s.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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