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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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| Model Number 8637-20 |
| Device Problems
Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Wound Dehiscence (1154); Bacterial Infection (1735); Pain (1994); Seroma (2069); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 02/07/2022 |
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Event Type
Injury
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Manufacturer Narrative
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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 patient who was receiving therapy via an implantable pump for unknown indications for use.It was reported that the pump was implanted higher and the patient's "breast fall on top of it".The caller mentioned they had "fluid" at the implant site and swelling in their back as well.Additional information was received from the consumer indicated that the healthcare provider thought the swelling was due to the medication.The patient was provided lasix and was to go back in if the swelling did not go down.The caller stated that the healthcare provider was concerned that they may have a staph infection.
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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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Event Description
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Additional information was received from the patient who reported that they aspirated the swelling once already and the incision is open.Per the patient, the swelling is at the pump implant site and where the catheter is on their back.She stated that she still had the binder on.Per the patient the catheter was placed in the same spot in her back (l3/l4) that her stimulator was initially placed.Per the patient, her stimulator had been removed because she was in a car accident.She stated that she hadn¿t had a refill yet but later made the comment about the drug increasing from 20 to 30 which did not have any effect on the other pains that she had.She confirmed that the pump therapy was working for the indication of pain which was her back.She stated that she did have pre-existing pain in her knee which would affect her upper back when she was doing tasks like making a meal or unloading the dishwa sher.An mri of her knee showed her knee was really messed up.She stated that she was given a ptm (personal therapy manager) and told to bolus every 2 hours to see if that helped with the other pain she experienced.The patient inquired about other medical procedures and information regarding x-ray, ct scan, and ultrasound was reviewed during the call.The patient was redirected to her healthcare provider.
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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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Event Description
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Additional information was received from a healthcare provider (hcp).With regards to if the cause of the swelling was determined, the hcp noted ¿yes¿.With regards to the actions taken to resolve the swelling and fluid buildup, the hcp noted ¿aspiration study¿.
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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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Event Description
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Additional information was received from a consumer indicated the pump sticks out of their abdomen and the patient inquired ¿is it supposed to be this noticeable?".It was reported the patient had a difficult recovery following pump implant with swelling, felt great with the trial, but pump was not helping.It was noted the pump was implanted for back pain and was told it may help with knee pain.The catheter was placed in l3-4, medication increased from 20 to 30, and the patient was hurting after performing activities of daily living (adls), and mentioned the trial was perfect, but with pump implant "i feel like shit".It was also reported that "this was the 10th time the [hcp] has operated on me, and he told me i have an inflammatory response when he operates on me, so that could be why i was swelling".Additional information was received again on (b)(6) 2022 from a consumer, and it was reported if the patient takes any narcotics they itch like crazy and must take medications for it.It was noted over the weekend they began to think the medication must not be dispensing, because they were in constant back pain and implied, they were not experiencing the itching.The patient inquired what tests could be done to confirm that.The patient was redirected to the hcp.
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Manufacturer Narrative
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Continuation of d10: product id 8780; serial# (b)(6); implanted: (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 was received from a consumer stating they were having the catheter side port test next week they think.Rfc patient was wondering how many times a catheter side port test has been done and what was to expect.Will the provider increase their medication slowly? patient repeated they does not feel they have been getting any medication probably since implant because they have not been getting any pain relief and had no itching.Patient stated they decided about 2 weeks ago that the catheter must be kinked or blocked or something.Patient stated they had dilaudid in the pump and said the dose/concentration was 30mg.Patient was redirected to provider.
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Manufacturer Narrative
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Continuation of d10: product id 8780 lot# serial# (b)(6), implanted: (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 a consumer (con) reported that the patient stated that they were having surgery again and "don't know why" but then went on to re-report the side port injection and something was "broken or kinked".The patient stated that the catheter was at t12 when it was supposed to be at t8.
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Event Description
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Additional information received from a healthcare provider indicated that diagnostics/troubleshooting performed had revealed the pump did have cerebrospinal fluid (csf) flow.The patient thought their medication wasn't working.The cause of the pump sticking out was normal protrusion.The cause of the pump not helping and pain since implant has not yet been determined; a work up is in progress.External factors that may have led to the event included patient psychological issues.Actions taken to resolve the pump sticking out, the pump not helping, and the catheter issue included checking the tubing and flow.The broken and migrated catheter has not been confirmed yet.No external factors led to the catheter issue.The event had been resolved.
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Manufacturer Narrative
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Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2022 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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