MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2023 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 8784 lot# serial# (b)(4) implanted: explanted: other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 05-dec-2024, udi#: (b)(4).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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Information was received from the healthcare provider (hcp) via the company representative (rep) regarding patient receiving lioresal (baclofen) (99.8 mcg/day / 2,000 mcg/ml) via implantable pump.It was reported that the catheter 8784 was opened and passed to the certified surgical technologist (cst) and then handed to the healthcare provider (hcp) to attach to the existing catheter spinal segment.The hcp took the collet and attempted to connect it to the catheter and asked if the collet pin was supposed to be bent with the plastic end piece off.They were given another 8784 to use for the procedure.The environmental/external/patient factors were unknown.The cst was going to try to bend the collet pin back straight, but i was concerned about patient safety and product performance, so i provided another 9784.
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Manufacturer Narrative
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Catheter: analysis identified the collet was {detached/missing} from the catheter-to-catheter connector.Analysis identified that the catheter was not fully seated onto the connector and the collet was locked in place.Visual inspection identified the pin connector was damaged which is consistent with explant damage.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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