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

Model Number 8637-20

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Fluid Discharge (2686)

Event Date 03/26/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2022, product type: catheter.Section.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 14-oct-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving gablofen (2000 mcg/ml at 118 mcg/day) via an implanted pump.It was reported that the patient had discharge from the site.The patient was taken to surgery for a possible catheter revision because of a csf (cerebrospinal fluid) leak.It was unknown if the issue was resolved at the time of the report.It was indicated that the hcp had no further information to provide regarding the event.

• 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: 13966346
• MDR Text Key: 288296399
• Report Number: 3004209178-2022-04065
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• UDI-Public: 00763000422608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• 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: 03/26/2022
• Date Device Manufactured: 12/14/2021
• 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): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male