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Correction to b5 and h10 other devices involved: d4: controller / (b)(4) / model #1407in / udi: (b)(4).H4: mfg.Date: 2017-05-01 h5: labeled for single use: no h6: device code: c63025 method code: fda 10, 4112 results code: fda 213 conclusion code: fda 4307 medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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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Product event summary: two controllers were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis revealed that (b)(4) passed functional testing.Visual inspection revealed a loose power port 1 connector.An internal inspection did not reveal evidence of fluid ingress.As a result, the reported loose connector was confirmed.(b)(4) had received the smr upgrade.Log file analysis revealed a controller power-up and associated pump start event logged on december 27, 2017 at 19:12:21.The data point prior to the controller power up event, at 19:03:59, revealed that (b)(4) was connected to power port 1 and (b)(4) was connected to power port 2 with 94% rsoc.The data point after the controller power up event, at 19:27:21, revealed that (b)(4) was connected to power port 1 and (b)(4) was connected to power port 2.The controller was without power for 8 minutes and 22 sec.Log file analysis also revealed a controller power-up and associated pump start event was logged on january 26, 2018 at 08:00:20.The data point prior to the controller po wer up event, at 07:53:23, revealed that (b)(4) was connected to power port 1 with 96% rsoc and (b)(4) was connected to power port 2 with 79% rsoc.The data point after the controller power up event, at 08:15:20, revealed that (b)(4) was connected to power port 1 and (b)(4) was connected to power port 2.The controller was without power for 6 minutes and 57 seconds.Several momentary disconnections were recorded leading up to the loss of power.Momentary disconnection will lead to an audible tone.As a result the reported beeping was confirmed.As a result, the reported pump stop event was confirmed.Failure analysis revealed that (b)(4) passed functional testing and visual inspection.The real time clock (rtc) was reset to zero, however, the controller was able to retain the date and the time when the real time clock was adequately charged.This is an additional observation not related to the reported event.The most likely root cause of the real time clock being reset to zero can be attributed to an extended period of time where the controller was not connected to an external power source, causing the real time clock to deplete.The most likely root cause of the reported beeping event can be attributed to momentary disconnections between the controller and batteries.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on both power sources.Based on an investigation, the most likely root cause of the reported loose power port event can be attribut ed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.There was an internal investigation initiated to capture events involving the controller losing power.There was an internal inves tigation for momentary disconnections.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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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