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 Muscular Rigidity (1968)

Event Date 05/02/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 30-oct-2021, 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 via a company representative regarding a patient receiving compounded baclofen 2000. 0 mcg/ml at 599. 9 mcg/day via an implantable pump. The patient¿s medical history stated ¿medical¿. Loss of therapy relief was reported. The patient was losing relief of her spasticity and felt this was due to the catheter not working properly. The environmental, external or patient factors that may have led or contributed to the issue was the patient had mentioned some falls in the previous month but there was no way of knowing if they were related to the therapy not being effective. The diagnostics and troubleshooting performed was the physician performed a dye study. At the dye study, the doctor was able to remove csf (cerebral spinal fluid) but unable to push the contrast through the catheter. The actions and interventions taken to resolve the issue was the catheter was replaced. The issue was resolved at the time of the report and it was noted that the healthcare provider would not have any further information 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: 14345010
• MDR Text Key: 291278274
• Report Number: 3004209178-2022-05947
• 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: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 05/05/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/01/2021
• 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: 05/10/2022 Patient Sequence Number: 1