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
Bowel Perforation (2668); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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Event Date 07/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8784, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2021, product type: catheter.Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2021, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 05-sep-2016, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: 15-dec-2016, 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 healthcare provider via a company representative regarding a patient receiving baclofen via an implantable pump.The indication for use was intractable spasticity.It was reported that the patient died.Per the reporter, at the pump replacement surgery in (b)(6), the surgeon allegedly ¿accidently tunneled through" the patient's bowel.The patient had health complications since that surgery and then passed away due to sepsis on or around (b)(6) day 2021.Additional information was received from a company representative who reported that the anesthesiologist asserted the opinion that it was the tunneling through the patient's bowel that was the cause of the patient's passing.Additional information was received from the managing healthcare provider on (b)(6) 2022 who reported that in (b)(6) of 2021, the patient was hospitalized for abdominal distension.The patient was taken into surgery to decompress their abdomen.During the surgery, it was noted that an intrathecal catheter had penetrated the colon.The hcp noted that this finding was incidental and unrelated to the abdominal distension.The catheter was clamped off during the surgery.It was also noted that the patient had an abdominal bleed following the surgery, considered unrelated to the device or therapy.With regards to the patient's sepsis and death, the hcp and the patient's surgeon (whom the hcp consulted with) confirmed that it was unrelated to the device or therapy.It was confirmed that no fecal matter had entered the catheter or had leaked out of the bowel as a result of the catheter penetration.No cause of death was provided, but the hcp noted that the patient was "not a very well individual".With regards to the catheter penetrating the bowel, the hcp suspects that this was a piece of the patient's previous catheter left in the body from the total system replacement in (b)(6) that had migrated through the peritoneum and into the bowel.Howe ver, the hcp was unable to confirm if this was the case as the cat scan they had ordered to determine if the catheter was connected to the pump or not was inconclusive.The cat scan only confirmed that a catheter had entered the bowel space.The hcp had no further information to provide.
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Manufacturer Narrative
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H6: corrected information: conclusion code d14 not applicable for the event.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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Manufacturer Narrative
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H6.Patient code: e2008 is also applicable to this event.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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