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Model Number 5392 |
Device Problems
Device Sensing Problem (2917); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Product analysis: analysis was able to confirm the customer comment that the external pulse generator (epg) required corrective maintenance/ repair.The epg failed > 20 tests on incoming testing.It was noted most errors were related to the atrial channel and the device was able to power on and boot up.The device was not working correctly and a new main board was required.It was noted the device was in good cosmetic condition and was not damaged.All found defective parts were replaced and all other identified issues were resolved.The instrument then passed all final functional tests.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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Event Description
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It was reported that the external pulse generator (epg) required corrective maintenance/ repair. the epg was returned for evaluation and subsequently tested out of specification during manufacturer's analysis. no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product analysis update: further analysis of the external pulse generator (epg) main board was performed.Upon visual inspection many resistors were noted to have lost screen-printed information ¿ possibly burnt or damaged.The main board was assembled into a golden unit and and failed all functional tests regarding the atrial channel.Upon benchtop analysis the unit was powered on and successfully started.It was then powered off and components investigated.It was found that a transistor was not functioning correctly and two resistors measured less than expected.It again failed all tests regarding the atrial channel.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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