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); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Seroma (2069)

Event Date 04/14/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving bupivacaine (10 mg/ml at 1.32 mg/day) via an implantable pump for spinal pain indications.It was reported that the patient experienced fluid collection in the pump pocket.There were no known factors that may have led or contributed to the issue.The physician dissected to expose the pump and no frank leakage was noted.There was sluggish aspiration at the cap (catheter access port) but the catheter cleared.The hcp disconnected the catheter connector from the pump and noted connector misshapen.A new pump connector was spliced to remaining spinal segment and calculations for catheter length corrected in settings.Upon aspiration of catheter post connection, more robust aspiration was noted.The pocket was irrigated and the pump was replaced. the issue was resolved at the time of report.The patient's status at the time of report was alive - no injury.

Manufacturer Narrative

Concomitant medical products: product id: 8780; serial#: (b)(4); implanted: (b)(6) 2021; explanted: (b)(6) 2022; product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 15-jan-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received that the patient was seen postop with increased fluids accumulation at pump pocket site; patient was brought to surgery for exploration where the distal segment of intrathecal catheter that had been left in place at time of replacement and tied off with sutures.It was discovered that the sutures used to tie off the catheter had loosened and slipped off of catheter thus allowing pocket to retain cerebral spinal fluid (csf).A purse string suture was applied to the old catheter insertion point and catheter removed and suture tightened; insertion point oversewed with ethibond suture.Observed field and no frank pooling was noted at the previous insertion point.The pump pocket was explored and fluid evacuated; and no further pooling or leaking was noted.The wounds were irrigated copiously with antibiotic irritation and routine closure was performed.

Manufacturer Narrative

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

The explanted portion of the pump segment of the catheter was returned for analysis.Analysis of that portion found ¿acceptable catheter testing catheter incomplete/returned segment.¿ 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

Corrected information - continuation of d10 should also have included: product id 8709 serial# (b)(6) implanted: (b)(6) 2004 explanted: tied off on (b)(6) 2021 then explanted on (b)(6) 2021 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8709 serial/lot# (b)(6), ubd 2006-07-19, udi# (b)(4).H6 ¿ corrected information: device code a050401 is not applicable.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.

• 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: 14146286
• MDR Text Key: 290467230
• Report Number: 3004209178-2022-04966
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• 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
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 04/19/2022; 07/20/2022; 07/20/2022
• Supplement Dates FDA Received: 04/22/2022; 07/20/2022; 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 80 KG