MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Material Frayed (1262); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Burning Sensation (2146); Electric Shock (2554)
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Event Date 02/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant products: product id: 97755, serial#: (b)(4), product type: recharger.Product id: 97755, serial#: (b)(4), product type: recharger.Product id: 97715, serial#: (b)(4), product type: implantable neurostimulator.Product id: 97715, serial#: (b)(4), product type: implantable neurostimulator.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4); product id: 97755, serial/lot #: (b)(4), udi#: (b)(4).Refer to regulatory report #(b)(4).Patient is currently implanted with 2 implantable neurostimulators and reports the same events for both rechargers.The referenced report pertains to the patients other system.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 patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the recharger cords are both coming apart and both are burning her on the ins site.The patient (pt) stated that the wires are cracked and shocked the pt.Patient services clarified if the pt felt shocking and the pt stated no, burning her.The pt stated that one is cracked at paddle port and the other is cracked where it connects to the stimulator.The pt stated that she had the recharger taped however the tape is now irritating her.The pt stated that she needs both rechargers replaced.
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Manufacturer Narrative
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Product id 97755; serial# (b)(6); was returned for analysis.Analysis found that the recharger telemetry module (rtm) cable was frayed, the cable insulation was peeling away at the donut end and the wires were exposed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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