MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)

Patient Problems Deposits (1809); Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via the manufacturer's representative (rep) regarding a patient who was receiving 20mg/ml of morphine at 6.5mg/day via an implantable pump.On 2022-jan-04, it was reported that, during a planned pump change when (elective replacement indicator) eri had been reached, a "massive crystalline morphine" was noted in the pump pocket.It was also reported that the connector approach showed contamination.The patient had not experienced any prior symptoms.The issue was considered resolved at the time of the event.The patient's status was listed as "alive - no injury".

Event Description

Additional information was received from the foreign healthcare provider (hcp) via the manufacturer's representative on 2021-(b)(6).It was reported that significant corrosion of the pump in the area of the pump segment catheter attachment was identified as the cause of the leakage.It was also noted that the pump connector itself was not checked for leaking.

Manufacturer Narrative

Continuation of d10: product id neu_unknown_cath lot# serial# implanted: explanted: product type catheter h6: updated to more accurately reflect the information received on 2022-(b)(6) and to reflect the new information received on 2022-(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 the foreign healthcare provider (hcp) via the manufacturer's representative on 2022-jan-12.It was reported that the patient's catheter was likely from around 2007, but the specific device information or implant date was unknown as all previous intervention occurred with outside facilities.A portion of the catheter end piece was also going to be returned with the pump.

Manufacturer Narrative

Continuation of d10: product id neu unknown cath , implanted: (b)(6) 2007.Product type catheter.Updated and correct to reflect the information received on 2022-jan-04 and on 2022-jan-12.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

H3: the pump was returned and analysis found no anomalies.The device passed all testing in the laboratory.H3: the catheter portion was returned and analysis found an indentation in the seal material in the cup of the sutureless connector (sc) which did not affect the performance of the 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 neu_unknown_cath implanted: (b)(6) 2007 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.

Event Description

Additional information was received via a foreign literature article.Reining m, kretzschmar m.Loss of effectiveness with an implanted drug delivery system for intrathecal pain therapy due to corrosion.Pain pract.2022;doi:10.1111/papr.13187 summary: intrathecal drug delivery is an established invasive treatment option.Most common complication is catheter malfunction, which can lead to overdose or withdrawal.Reported events: it was reported that "during the most recent admission interview at our hospital, the patient complained about the loss of effectiveness in the past year.Her pain physician increased the daily intrathecal dose from 5.5 to 6.5 mg morphine with inadequate effect and subsequently prescribed oral morphine drops as needed (max.25 mg per day).Mri performed 2 years earlier and no evidence of granuloma at catheter tip we scheduled the replacement of the intrathecal pump without further diagnostic procedures under general anesthesia, with a plan for intraoperative fluoroscopic evaluation of the catheter with a contrast agent if needed.In addition, we scheduled an intraoperative inspection and replacement of the proximal 15-year- old catheter if there were any signs of porous material.Informed consent was obtained for all procedures.Intraoperatively, a white mass with a soggy consistency was found in the entire pump pocket, corresponding to partially crystallized morphine.With a visually intact catheter, significant corrosion at the pump-catheter connection site on both the pump and the catheter sides could be identified the pump was replaced as planned with a capsulectomy.The first 15 cm of the pump segment of the catheter with the connector was also replaced.As clear cerebrospinal fluid flowed back from the cut catheter, we assumed the catheter was intrathecally placed and refrained from intraoperative contrast agent imaging.The patient was discharged after a complication-free course with a daily morphine dose of 2.5 mg and significantly improved pain relief.The scar tissue of the capsule around the pump was sent for histopathological examination where crystalline structures without any i nflammatory reaction were observed.Unfortunately, we could not validate that the crystalline structures corresponded to morphine as we do not have access to mass spectrometry at our hospital." see attached literature article.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13179573
• MDR Text Key: 290569638
• Report Number: 3004209178-2022-00261
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female