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

Model Number 8637-20

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Information was received from a consumer and a healthcare provider (hcp) via a company representative regarding a patient receiving baclofen (1000 mcg/ml at 75 mcg/day) via an implanted pump. The patient reported that the system was not functioning. A cap (catheter access port) procedure was done, and the catheter did not aspirate. It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue. The patient was taken in for a revision and the pump segment of the catheter was replaced. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.

Manufacturer Narrative

Continuation of concomitant medical products: product id 8596sc, serial# (b)(4), implanted: (b)(6) 2017, explanted:(b)(6) 2022, product type: catheter, ubd: 21-jul-2018, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

• 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: 14239319
• MDR Text Key: 290309542
• Report Number: 3004209178-2022-05382
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/28/2022 Patient Sequence Number: 1