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

Model Number	8637-20
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2018 explanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 03-oct-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal lioresal 2000 mcg/ml at 99 mcg/day via an implanted pump.It was reported the hcp was unable to aspirate the catheter.The catheter was replaced with a new 8780 on (b)(6) 2021 and the previous catheter was discarded.It was further reported the patient was experiencing withdrawal symptoms.The physician was unsuccessful at aspirating cerebrospinal fluid (csf) from the catheter.It was unknown if there were any environmental, external, patient factors that may have led or contributed to the issue.The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury.¿ the patient¿s weight and medical history were asked and would not be made available.

• 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
• MDR Report Key: 12153748
• Report Number: 3004209178-2021-10691
• Device Sequence Number: 3774792
• Product Code: LKK
• UDI-Device Identifier: 00643169984219
• UDI-Public: 00643169984219
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR