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

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Muscular Rigidity (1968)

Event Date 06/17/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving baclofen (500 mcg/ml at 99 mcg/day) via an implantable pump.It was reported that at the scheduled pump refill on (b)(6) 2022, the physician found 18 ml of baclofen in the pump's reservoir while the expected volume was 1.8 ml.Regarding diagnostics/troubleshooting performed, it was indicated that reading notes, no abnormal events were reported.At the last refill on (b)(6) 2022, there was no anomaly during refill.The patient presented stiffness.The physician was considering arranging a session to check for possible kinking of the catheter with the contrast medium.Factors that may have led or contributed to the issue were unknown.The issue was not resolved as of (b)(6) 2022.The patient's medical history, gender, age, and weight at the time of the event was unknown or would not be made available.Additional information was received from a foreign healthcare provider via a company representative on 2022-jun-21.On (b)(6) 2022 a rotor test showed no abnormalities.It was further noted that on the other hand, direct access to the catheter revealed a catheter obstruction.A catheter revision was to be carried out in july.

Manufacturer Narrative

Concomitant medical products: product id: 8780, lot#: unknown, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# unknown serial# implanted: (b)(6) 2021 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 from the foreign healthcare provider (hcp) via the manufacturer's representative (rep) on 2022- jun-27.It was reported that the patient's catheter was implanted in (b)(6) 2021 and the catheter kink was suspected, but had not been confirmed.A date for the revision, during which the presence of a kink will be verified, had not yet been scheduled.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# unknown serial# implanted: (b)(6) 2021 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 from a company representative.Surgical revision of the implant took place yesterday ((b)(6) 2022).Kneeling catheter at pump outlet.To be on the safe side, the doctor replaced the entire catheter anyway.

Manufacturer Narrative

Continuation of d10: product id 8780, implanted: (b)(6) 2021, 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 from the foreign healthcare provider (hcp) via the manufacturer's representative (rep) on (b)(6) 2022.It was clarified that the catheter was kinked outside the catheter access port.The catheter was explanted and discarded.The issue and the patient's stiffness were considered resolved.

• 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: 14758504
• MDR Text Key: 295034595
• Report Number: 3004209178-2022-07927
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Date Device Manufactured: 06/15/2020
• 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...."; "SEE H10...."; SEE H10....; SEE H10....
• Patient Outcome(s): Required Intervention