MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Pain (1994); Scar Tissue (2060); Numbness (2415); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8703w, lot# l78719, implanted: (b)(6) 2000, product type: catheter.Other relevant device(s) are: product id: 8703w, serial/lot #: (b)(4), ubd: , 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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On 2021-aug-30, information was received from a patient receiving bupivacaine (6.126 mg/day) and dilaudid (13.987 mg/day) via an imp lantable pump for spinal pain.The patient reported that starting a couple of years ago, the have been having a problem "where the catheter goes into the spinal cord".The patient stated their surgeon calls it "an aneurysm, others call it a cyst".The patient stated that because of the "cyst", [the patient] gets "nerve pain, like someone's shocking [them]".The patient stated the "electrical shock goes around bad in my back on the right side".The patient stated that due to the "shocking", they rub that side and have "rubbed myself so hard" that they have scars on that side.The patient stated they have lost feeling totally on the left side from the waist down and in their privates.The patient called due to inquiries related to the catheter.The patient was redirected to their hcp to further discuss their medical concerns.The patient then mentioned that on wednesday, the hcp decreased the medication to attempt to shrink the "cyst".The patient stated their current dose of dilaudid was 13.987 and bupivacaine was 6.216 and stated the previous dosage had been that way "for years".The patient called back and reported they wanted to take the medication out of the pump for 6.8 months and see if it goes away.The patient stated they did not want to go back to oral medications.The patient stated they have scars on her from her holding her pain which is nerve pain.The rolls of manufacturer representative (rep), healthcare professional (hcp) and the manufacturer were reviewed.The patient was redirected to their hcp.Additional information was received from the healthcare provider via a device manufacturer representative indicated that the patient had a possible granuloma at tip of the catheter and that the patient wanted it replaced.
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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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Event Description
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Additional information was received from the company representative that no further action was taken at this time.The managing physician referred the patient to another surgeon for consult.No appointment had been set up as of this date.
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Search Alerts/Recalls
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