MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Failure to Interrogate (1332); Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900)
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Patient Problem
Burn(s) (1757)
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Event Type
malfunction
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was that the recharger (rtm) cable was broken as right at the end where the cable goes into paddle there was a little hole in the wire.Pt stated that the rtm was burning them real bad and that they were not able to recharge their ins.Pt stated that they were trying to recharge the ins for like four hours this morning, however the device couldn't find the recharger.Pt stated that they had been having problems recharging their ins for awhile, but that as long as they moved the rtm around their back then the ins would recharge; pt stated that today was the first day that they couldn't get the ins to recharge at all.The patient was sent out a replacement recharger (rtm).
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Manufacturer Narrative
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Section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), ubd: , udi#.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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H3: product id 97755, serial# (b)(6), was returned for product analysis.Analysis of the device found a frayed cable, the cable insulation is peeling away at donut end and wires are exposed; in addition a recharger failure was noted- the 'no device found' message was seen.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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