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

Model Number	8637-40
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Itching Sensation (1943); Muscular Rigidity (1968); Irritability (2421); Insufficient Information (4580)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving gablofen via an implantable pump.It was reported that the patient experienced agitation, itching in groin and increased tone.Baclofen withdrawal suspected.The patient was treated with oral baclofen and oral valium, 65 mcg single bolus of baclofen given via pump.The patient responded to bolus with decreased tone, decreased agitation, decreased clonus, and decreased itching.The baclofen dose was serially increased from 271.5 mcg/day to 622 mcg/day over a 2 year period.On (b)(6) 2022 a dye study was completed in preparation for pump replacement.During replacement surgery tissue noted around pump connector, requiring the spinal portion to be cut from pump.After replacement of spinal segment, slow egress of cerebrospinal fluid (csf) noted, a kink in the catheter was identified and resolved with repositioning and anchoring of catheter connector.Csf flow improved post revision compared to pre-revision.
Additional Manufacturer Narrative
Continuation of d10: product id 8596sc, serial# (b)(6), implanted: (b)(6) 2012.Product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(6), ubd: 02-may-2014, 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 ; +1(763)526-5677
• MDR Report Key: 50434123
• Report Number: 3004209178-2026-14353
• Device Sequence Number: 13131451
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 10/14/2017
• 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: 08/07/2026
• Initial Report FDA Received Date: 08/25/2026
• Date Device Manufactured: 04/23/2016
• 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: 26 YR
• Patient Sex: Male
• Patient Weight: 71 LB