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Model Number 5392 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: it was determined on analysis that the external pulse generator (epg) tested out of specification as it was identified that the main printed circuit board (pcb), was contaminated.The customer comment confirmed the menu parameter dial was pushed in and was no longer attached, the upper case was broken, and the encoder was pushed inside of the device.It was also determined at analysis that the output connector and hanger assembly were broken.The capacitor c277 was damaged on main pcb.The epg failed the incoming functional tests for ventricular and atrial pace pulse noise.The main pcb was out of specification electrical.The encoder stems were contaminated, but functional.Two knobs were missing, and two knobs were contaminated.The lower case was broken.The liquid crystal display (lcd) display and the display frame were contaminated.All found defective parts were replaced and all other identified issues were resolved.The device 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)'s bottom knob was pushed in and no longer attached.The epg has been received in for evaluation and subsequently tested out of specification during manufacturers analysis.There was no patient involvement.
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Manufacturer Narrative
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Product analysis update: further analysis of the external pulse generator (epg) was performed.The main board and lcd were assembled into a golden unit.Upon functional test ran on tester the device failed atrial and ventricular pace output noise tests.Upon benchtop analysis atrial and ventricular pace pulse noise were measured using o-scope and were found to be within the requirements of pace pulse noise 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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Search Alerts/Recalls
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