MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 37712 |
Device Problems
Break (1069); High impedance (1291); Battery Problem (2885); Connection Problem (2900); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 39565-65, serial# (b)(4), implanted: (b)(6) 2011, product type lead.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 11-oct-2014, udi#: (b)(4).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 a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the rep met with patient for scheduled ins replacement due to normal battery depletion.Unable to check impedance pre op.Ins already dead.The healthcare provider (hcp) had difficulty removing lead from 0-7 channel on previous ins.Also, when we were removing leads from ins rep and hcp noted that paddle lead was connected incorrectly.0-7 was the right side of lead.They were able to remove 8-15 without difficulty.Hcp noted that the right lead was frayed between contacts at the connection site.They properly inserted the leads into appropriate channels.Connection check show 14-15 as red.Impedance check showed electrodes 10 and 15 as greater than 40000.The hcp wiped down contacts, and we were unable to get a better connection.In post anesthesia care unit (pacu), rep and hcp were able to get adequate coverage needed, and the pt is happy.The issue was resolved.No environmental issues were reported to have contributed to the event.The patient is alive with no injury.
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