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); Material Integrity Problem (2978); Insufficient Information (3190)
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Patient Problem
Seroma (2069)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8731sc, serial#: (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2022, product type: catheter; product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2009 , explanted: (b)(6) 2022 product type: catheter ; other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 05-jun-2009, udi#: (b)(4); product id: 8598a, serial/lot #: (b)(4), ubd: 17-sep-2009, 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 (hcp) via a company representative regarding a patient receiving prialt/ziconotide via an implanted pump.It was reported that the pump pocket was filling with fluid that required draining every few days.The hcp believed the seroma may be related to the catheter.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The hcp performed a dye study on (b)(6) 2022 and the dye study was inconclusive.A catheter replacement was planned for (b)(6) 2022.The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event.
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Manufacturer Narrative
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Continuation of d10: product id 8731sc lot# serial# (b)(6) implanted: (b)(6) 2007, explanted: (b)(6) 2022, product type catheter p roduct id 8598a lot# serial#(b)(6) , implanted: (b)(6) 2009,explanted: (b)(6) 2022,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 received from the company representative stated that the pump flipped has been resolved.The catheter was replaced and pump secured in pocket.
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Event Description
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Additional information received from the company representative indicated that the cause of the fluid/seroma at the pump pocket during the procedure was that the pump was flipping and the catheter broke.
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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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Manufacturer Narrative
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The catheter was returned, analysis found no significant anomaly on the catheter and a compressed body area on the catheter spinal segment revision kit.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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