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Model Number 8637-20 |
Device Problems
Premature Elective Replacement Indicator (1483); Inappropriate or Unexpected Reset (2959)
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Patient Problem
Cognitive Changes (2551)
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Event Date 03/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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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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Information was received from a healthcare professional and a manufacturer representative regarding a patient receiving bupivacaine 18.0mg/ml for a total dose of 0.109 minimum mg/day and dilaudid (hydromorphone) 12.0 mg/ml for a total dose of 0.072 minimum mg/day via an implantable pump for failed back surgery syndrome and spinal pain.It was reported alarm heard/ confirmed by telemetry.Healthcare professional (hcp) stated patient presented to the hospital today ((b)(6) 2017) with altered mental status.Hcp stated the attending hcp ordered the pump to be turned down, but when they interrogated the pump they realized the pump could not be turned down.It was reported a critical alarm occurred, low battery reset occurred, safe state occurred, and elective replacement indicator (eri) occurred.It was noted when they interrogated the pump the logs showed eri occurred on (b)(6) 2017 even though the print showed eri was 17 months.It was stated on (b)(6) 2017 low battery reset and safe state occurred.It was noted that the pump logs were checked and no troubleshooting was done on call.It was reviewed to consider managing the patient by other medications (oral medication), and consider programming out of the reset.It was reviewed the likelihood of the reset occurring again and reviewed replacing the pump and sending the pump back for analysis.Hcp was redirected to contact/follow up with managing hcp and the attending hcp to review the reset information.The altered mental status was noted as a sudden change in symptoms/therapy.Event date was noted as (b)(6) 2017.It was later reported from a manufacturer representative that the logs were checked and showed multiple resets, reset low battery and safe state logs starting (b)(6) 2017.Pump replacement and sending the pump back for analysis was discussed.No further complications were reported/anticipated.
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Manufacturer Narrative
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Updated to reflect the information received on 2017-jun-26 regarding the pump being replaced: updated to reflect the information received on 2017-jun-26 section: updated to reflect the facility associated with this event: updated to reflect the information received on 2017-jun-26 regarding the pump being replaced medtronic, inc.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider via a manufacturer's representative regarding a patient who was receiving 2 mg/ml of morphine at 0.3 mg/day and 12 mg/ml of bupivacaine at 1.8 mg/day via an implantable pump for non-malignant pain.On (b)(6) 2017, it was reported that, during a pump replacement procedure, that the pump was in "shelf state" and alarming.No bolus dose was performed as a result.The catheter was unchanged during the procedure and was at 69 cm.No symptoms were reported related to the alarming pump.It was reported that the patient had died, but the patient's death was not considered to be related to the device.It was suspected that the patient's death was most likely due to complications unrelated to the pump.Additional information was received on 2017-jun-28 from the manufacturer's representative.It was reported that the patient's pump was at 10 months eri and the pump was scheduled to be replaced around that time.During a pump interrogation the day of the replacement, the pump was in "shelf state" and was alarming because of a low battery reset.The hcp did not provide any details regarding symptoms related to the pump being in "shelf state", nor was the patient aware of the pump being "shelf state".The pump reportedly continued to alarm throughout the procedure, alarming once per minute while the replacement was being made.No actions were taken as the alarm was discovered a few minutes prior to the pump being replaced.The cause was not determined.The issue was not considered resolved as the pump continued to alarm after being explanted.Additional information was received on 2017-jun-30 from the manufacturer's representative.It was reported that the pump that was alarming was the pump being replaced and that the pump was alarming due to safe state, rather than "shelf state".It was also reported that there were no plans to return either pump to the manufacturer.No further complications were reported.
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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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Manufacturer Narrative
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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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