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

Model Number 8637-20

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8782, serial# (b)(4), implanted: (b)(6) 2020, explanted: product type: catheter.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 18-jul-2020, 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 dilaudid (1 mg/ml at 0.1 mg/day) via an implantable pump for non-malignant pain and failed back syndrome - other.It was reported that the patient recently presented to the healthcare provider (hcp) office with complaints of poorly controlled pain.Given their history of a previous catheter obstruction and revision ((b)(4)), they were concerned that this had happened again.An external factor that may have contributed to the event was the previous revision at which time the distal segment had been replaced with an (b)(4) revision kit.Diagnostics/troubleshooting performed included a (b)(6) study at the hcp office on (b)(6) 2022.Their dosing was subsequently reduced in preparation for a catheter revision surgery.Actions/interventions taken included taking the patient was taken to the operating room today.They were placed in a right lateral position.The hcp opened up the pump pocket and dissected out the pump and proximal segment of the catheter.Once the catheter was ¿freed¿ from the tissue, the hcp then attempted to aspirate from the catheter access port again and this time got a positive return of cerebrospinal fluid (csf).No parts of the catheter were removed/replaced.The drug in the reservoir was changed from morphine to dilaudid before re-implanting the pump, so a back table prime was completed.After the back table prime was done, the pump was reattached to the proximal pump segment and placed back in the pocket.A final catheter aspiration was completed with positive return of csf again.A final priming bolus was completed to replace the drug that was removed from the catheter and begin infusion.The event was resolved at the time of the report.

• 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: 14601868
• MDR Text Key: 293350319
• Report Number: 3004209178-2022-07196
• 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: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/06/2022
• Date Device Manufactured: 07/17/2019
• 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: Male