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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Date 01/30/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from multiple sources (healthcare provider (hcp), foreign, clinical study) regarding a patient who was receiving lioresal (baclofen) via an implantable pump for unknown indications for use.It was reported that the nurse call on sunday morning (b)(6) 2022 because fluid was coming out and the scar was open 1cm.  the clinical diagnosis was liquid coming of the scar.Additional information received from a foreign healthcare professional (hcp) via a clinical study provided the patient's gender.It was noted the other patient information (initials/first and last name and age/date of birth) were not collected.Additional information received from a foreign healthcare professional (hcp) via a clinical study the outcome of the event resolved without sequelae on (b)(6) 2022.The etiology of the event indicated the relationship of the event to the device or therapy was not related and indicated the relationship of the event to the implant procedure was related.The patient was receiving lioresal 640 mcg/ml at 310.23 mcg/day.Additional information received from a foreign healthcare professional (hcp) via a clinical study reported examination on (b)(6) 2022 revealed the scar seemed to be superficial.Examination on (b)(6) 2022 revealed fluid was still coming out and the fluid was tested for an infection.Laboratory testing was done on (b)(6) 2022 where they tested the fluid and blood.Additional informa tion received from a foreign healthcare professional (hcp) via a clinical study reported the patient came to the hospital on monday (b)(6) 2022.It was noted the scar was open superficially and even after putting pressure on both parts of the scar, nothing came out so a dressing change occurred with betadine cream.The day after, the received a call because new fluid was coming, so the patient came in again and fluid came out after a lot of pressure.Testing was done where the fluid and blood were tested in lab.The patient received antibiotics.Results showed c-reactive protein was 188 and leukocytes was 12.8.The decision was made to explant/not replace all the system on (b)(6) 2022.The clinical diagnosis was updated to leakage on the scar.

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.

Event Description

Additional information received from a foreign healthcare professional (hcp) via a clinical study.The clinical diagnosis was infection on the implant site scar.Device disposition was unknown.

Event Description

Additional information received from a foreign healthcare professional (hcp) via a clinical study reported the event required in patient or prolonged hospitalization and resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function.The device diagnosis was updated to other infection and the clinical diagnosis was infection on the scar.The outcome of the event was updated to resolved without sequelae on (b)(6) 2022.

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.

• 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: 13619812
• MDR Text Key: 286370535
• Report Number: 3004209178-2022-02571
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Date Device Manufactured: 04/01/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 64 KG