MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Overheating of Device (1437); Charging Problem (2892); Insufficient Information (3190)
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Patient Problem
Burn(s) (1757)
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Event Date 03/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant products: product id: 97755, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), 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 consumer regarding a patient with an implantable neurostimulator (ins).Information was received from a patient (pt) regarding an external device, recharger (rtm) with serial number (b)(4).The patient reported that for the last 2 weeks they had been having problems with the recharger.Patient spoke with rep who told them to call pats for a new recharger (rtm).When patient was having trouble connecting, the controller kept saying to move around the rtm and the patient was unable to charge.Patient reported that when they are finally able to get the rtm connected, it over heated and burned their skin (left a red mark).They reported that where the wire goes into the paddle is where it got hot and burned them.Patient said the cord was almost to the point where they couldn't touch it.Patient said they laid the rtm on the table and the whole thing was scalding hot and the controller battery had gone completely dead within a few minutes.Patient inspected the rtm and did not notice any physical damage.The issue was not resolved.An email was sent to the repair department to replace the device.
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Manufacturer Narrative
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Continuation of d10: product id 97755 lot# serial# (b)(6).Implanted: explanted: product type recharger h3: analysis of the recharger found a recharge antenna failure and the device was scrapped after failing bench testing.H6: fdc 4315 pertains to the recharger.Fdm 10 and fdr 120 pertain to the recharger.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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Search Alerts/Recalls
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