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

Model Number 8637-40

Device Problem Infusion or Flow Problem (2964)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8703w, lot#: l60552, implanted: (b)(6) 1999, product type: catheter. Other relevant device(s) are: product id: 8703w, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving unknown baclofen via an implantable pump for unknown indications for use. It was reported that the patient had a return of symptoms. There was no environmental/external/patient factors that may have led or contributed to the issue noted. A catheter dye study was performed and was unsuccessful. It was noted the hcp did not push dye through the catheter so was unable to determine catheter patency at that time. The issue was not resolved.

• 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: 14462328
• MDR Text Key: 292504064
• Report Number: 3004209178-2022-06528
• Device Sequence Number: 1
• Product Code: LKK
• 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

• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial