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

Model Number 8637-20

Device Problem Obstruction of Flow (2423)

Patient Problem Itching Sensation (1943)

Event Type  Injury  

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving compounded baclofen 2 000mcg/ml at 400mcg/day and bupivacaine 40mg/ml at 8.0 mg/day.It was reported that the patient had return of symptoms post refill week of (b)(6) 2022.There were no falls or issues in regards to if there were any environmental, external or patient factors that may have led or contributed to the issue.The diagnostics and troubleshooting performed was they re-accessed the pump and was able to aspirate all drug back, so not a pocket fill; the physician believed ¿kinking or suture less connection¿ was causing issues.They checked the reservoir for any discrepancies.The physician noted the difficulty at last refill and the patient had return of itchiness and withdrawal baclofen symptoms.The physician decided to repair surgically and determined the excessive catheter length or trimmed at implant was bending and causing kinking, also possibly fat distribution slightly clogging the sutureless connector.The pump segment replaced and catheter was aspirating with no issue.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.

Manufacturer Narrative

Concomitant products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 16-may-2021, 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: 14192111
• MDR Text Key: 289953135
• Report Number: 3004209178-2022-05170
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• 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: 04/19/2022
• Date Device Manufactured: 05/29/2019
• 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 Sex: Female
• Patient Weight: 27 KG