MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Migration or Expulsion of Device (1395); Obstruction of Flow (2423)
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Patient Problems
Lethargy (2560); Insufficient Information (4580)
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Event Date 02/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 22-jun-2022, udi#: (b)(4).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 consumer regarding a patient receiving baclofen and dilaudid via an implanted pump.The indication for pump use was intractable spasticity.The patient reported that she was in the hospital because her pump was malfunctioning.She stated that ¿it¿s moved, it flipped 180 degrees¿ and ¿the line is pinched¿.She stated that she didn¿t know if she was getting too much or not enough, but right now she knew she was getting to much because her fiancé was having trouble waking her up.The issue began last week.She stated that her doctor was trying to make her wait until the 22nd to fix it.She was calling for physician listings for other pump managing doctors and surgeons.
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Manufacturer Narrative
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Continuation of d10: product id 8780 serial# (b)(6) implanted: (b)(6) 2020 product type catheter 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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Additional information was received from the patient stated to resolved the pump moving/flipping and the line/catheter being pinched, they cut a deeper incision, put under deeper layer of muscle, sown down completely around pump except forline.The device is still implanted.
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