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); Communication or Transmission Problem (2896)
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Patient Problems
Pain (1994); Seroma (2069)
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Event Date 11/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id neu_unknown_cath lot# serial# unknown implanted: explanted: 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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Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving bupivacaine and dilaudid (hydromorphone) via an implantable pump for unknown indications for use.It was reported that the patient had pain at the pump and catheter site.The catheter site pain resolved without intervention.Examination revealed that the pump pocket had a seroma.400 ml of fluid was aspirated from the site.She was instructed to resume wearing her abdominal binder and was scheduled for evaluation.On (b)(6) 2022 examination revealed a persistent seroma.150 ml of fluid was aspirated from the site.The seroma caused some difficulty connecting the personal therapy manager (ptm) and pump.Additional information received from the healthcare provider via a clinical study indicated that the patient felt that her pump had migrated and that a stitch might have broken.The patient reported pain at the pump site, likely secondary to pump inversion.The inversion was likely the cause of the patient's difficult y connecting to their personla therapy manager (ptm).The healthcare provider aspirated 63 ml from a seroma at the pump site.The plan is to revise the pump revision.
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Manufacturer Narrative
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Continuation of d10: product id: neu_unknown_cath, 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.
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Event Description
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Additional information received from the healthcare provider via a clinical study indicated that the pump was replaced and that a new pocket was created and anchored with two suture loops.
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Search Alerts/Recalls
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