BOSTON SCIENTIFIC NEUROMODULATION INFINION 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-2316-50 |
Device Problems
High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Intermittent Energy Output (4025)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Exact date unknown, event occurred in (b)(6) 2020.Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2316500, model: sc-2316-50, serial: (b)(4), batch: 18989440.
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Event Description
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It was reported that after a magnetic resonance imaging was performed, the patient experienced intermittent stimulation, overstimulation when standing up, inadequate stimulation, and loss of stimulation while lying down.High impedances on the leads were noted.The patient underwent a lead replacement procedure and was doing well postoperatively.The explanted leads will not be returned.
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