Model Number 8637-40 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
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Patient Problems
Dyspnea (1816); Numbness (2415)
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Event Date 02/28/2019 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_cath, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath.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 the healthcare provider (hcp) via device manufacturer representative regarding a patient receiving bupivacaine and dilaudid at an unknown concentrations and doses via an implantable infusion pump.It was reported that during a dye study the hcp was unable to aspirate cerebrospinal fluid (csf) from the catheter access port (cap) so the patient got a bolus of his medication when the dye was injected.It was noted that post dye study that patient became short of breath and ¿numb¿ from the abdomen down and was sent to the emergency room.The issue was reported to be resolved and the patient was alive with injury.No further complications have been reported as a result of this event.
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Event Description
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On 2019-apr-10, additional information was received from the manufacturer representative (rep).The rep stated the patient was scheduled for a pump replacement on (b)(6) 2019 due to early replacement indicator (eri)/end of service (eos).The hcp was unable to aspirate the catheter from the catheter access port (cap) of the old pump.There were no obvious tears or leaks at the pump segment, so the hcp made an incision at the spine and the catheter was fractured at the anchor site.The old 8780 ascenda catheter was removed in its entirety and a new 8780 ascenda was implanted.The hcp was able to successfully aspirate from the new catheter and old catheter was sent to pathology and would be returned after it was returned from pathology.
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Manufacturer Narrative
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Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2019, product type catheter.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 healthcare provider (hcp) indicated that the cause of the inability to aspirate the catheter was due to an unknown catheter occlusion.No further complications have been reported as a result of this event.
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Manufacturer Narrative
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Concomitant medical products: product id 8780 serial# (b)(4) implanted: (b)(6) 2013 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 healthcare provider (hcp) via a device manufacturer representative indicated identifying information related to the device and patient involved in the event.No further complications have been reported as a result of this event.
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Manufacturer Narrative
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Continuation of d11: product id (b)(6).Lot# serial# (b)(4).Implanted: (b)(6) 2013 explanted: product type catheter medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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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H3: the returned devices passed all testing in the laboratory and no anomalies were identified.Continuation of d11: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2013.Explanted: (b)(6) 2019.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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Search Alerts/Recalls
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