Model Number RVDR01 |
Device Problems
Unable to Obtain Readings (1516); Loss of Data (2903); Impedance Problem (2950); Output Problem (3005); Reset Problem (3019)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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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 implantable pulse generator (ipg) experienced a power on reset.It was also reported that there was a bitflip in the lead and impedance and battery trends.It was also reported that the ipg was not registering a battery voltage.The ipg was interrogated as a result.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a software error.Analysis of the device memory indicated the battery measurement was not available.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction: b2, b5 <(>&<)> h6 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 implantable pulse generator (ipg) experienced a power on reset.It was also reported that there was a bitflip in the lead and impedance and battery trends.It was also reported that the ipg was not registering a battery voltage.The ipg was interrogated as a result.No patient complications have been reported as a result of this event.On (b)(6) 2020 the ipg reached elective replacement indicator (eri); was explanted and replaced.
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Search Alerts/Recalls
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