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

Model Number	8637-40
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Muscular Rigidity (1968)
Date of Event	06/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving compounded baclofen (1750 mcg/ml at 650 mcg/day) via an implanted pump.It was reported that the patient complained of increased spasticity in their legs in the recent ¿couple months.¿ any environmental, external, or patient factors that may have led or contributed to the issue were denied.The hcp did a rotor dye study and there was minimal csf (cerebrospinal fluid) aspirated from cap (catheter access port).The patient was going to be scheduled for a catheter replacement in the future since the catheter was 20 years old and the patient stated that the spasticity was worse in certain positions.The surgery was not yet scheduled.The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event at this time.
Additional Manufacturer Narrative
Continuation of d10: product id 8709 lot# serial# (b)(6); implanted: (b)(6) 2004; product type catheter product id 8578 lot# serial# (b)(6); implanted: (b)(6) 2018; 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: 06-jan-2006, udi#: (b)(4); product id: 8578, serial/lot #: (b)(6); ubd: 19-apr-2020, udi#: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SYNCHROMED II
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19960338
• Report Number: 3004209178-2024-16493
• Device Sequence Number: 12528953
• Product Code: LKK
• UDI-Device Identifier: 00643169984226
• UDI-Public: 00643169984226
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/12/2024
• Date Device Manufactured: 07/27/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male