MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Emotional Changes (1831); Unspecified Infection (1930); Pain (1994); Vomiting (2144); Insufficient Information (4580)
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Event Date 07/14/2022 |
Event Type
Injury
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Event Description
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Information was received from a friend/family member regarding a patient who was receiving unknown drug via an implantable pump for unknown indications for use.It was reported that the patient had "been suffering for 2 weeks" since their catheter replacement on (b)(6) 2022.The patient representative reported that the patient was "in pain and crying and everything else since the tube was put in" as well as in "constant pain" and "getting sick and vomiting".The patient representative stated that the catheter got infected where they put it in and now the patient was on antibiotics.The patient representative also mentioned that the ptm was locking the patient out for longer than the programmed 3 hour lockout, noting that the patient has been locked out for 8 hours 7 minutes, 5 hours, 6 hours 47 minutes, etc.The patient representative confirmed that the patient was currently locked out.They obtained the handset and confirmed that the current lockout was due to dri (dose restriction interval).The patient representative commented that they believed the handset to be at fault because they noticed the handset had increased difficulty finding the pump.Patient services r eviewed general repositioning of equipment during the call and the equipment connected as anticipated.The patient representative stated that they spoke with the healthcare provider and nurse practitioner who programmed the patient's pump so they do not believe dr i was the cause of the lockouts and asked if the ptm could be misinterpreting the lockout time from the pump.Patient services reviewed and reiterated that dri does not indicate a faulty ptm.The patient representative stated that they have an appointment with the healthcare provider today ((b)(6) 2022).When asked about medication information, the patient representative stated that there were 3-4 different medications and thought one of them was morphine.
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Manufacturer Narrative
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Concomitant medical products: product id 8781 lot# serial# (b)(4) implanted: (b)(6) 2022 product type catheter.Product id a820 product type software.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 25-feb-2024, udi#: (b)(4).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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