MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-20 |
Device Problems
Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Material Integrity Problem (2978)
|
Patient Problem
Twiddlers Syndrome (4563)
|
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from healthcare provider (hcp) via representative (rep) regarding a patient receiving unknown drug via an implantable pump.It was reported that the patient¿s pump had flipped.The healthcare provider believed the tethers he used to secure the pump have been ripped out.The patient had been manipulating her pump.It was noted imaging and refill attempts confirmed pump flipped and un-flipped status.Surgery was required to restructure the patient¿s pocket and replaced the tether sutures.Surgery has been scheduled for (b)(6) 2022 since surgery was required.The issue was not resolved and the patient's status was "alive- no injury".Patient weight and medical history was asked but unknown.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 8596sc lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2022 product type catheter product id 8596sc lot# serial# (b)(6) implanted: (b)(6) 2021 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.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 8596sc lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2022 product type catheter pr oduct id 8596sc lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2022 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8596sc serial/lot# (b)(6), ubd (b)(6) 2023, udi# (b)(6) 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.
|
|
Event Description
|
Additional information was received from a healthcare provider (hcp) via a company representative who reported that the surgery was successful.It was noted that a catheter revision was necessary because the patient had twisted the catheter so badly.The issue was now resolved.
|
|
Search Alerts/Recalls
|
|
|