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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Kinked (1339); Volume Accuracy Problem (1675)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): product id: 8781, lot# serial# (b)(6), implanted: (b)(6) 2013, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 24-may-2015, udi#: (b)(4).(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 clinical study regarding a patient receiving dilaudid (1.5 mg/ml at 0.3600 mg/day) and bupivacaine (30.0 mg/ml at 7.200 mg/day) via an implanted pump.The indication for use was non-malignant pain.It was reported the patient presented for a pump adjustment secondary to increased lower back pain on (b)(6) 2018.A reservoir volume discrepancy was noted at the patient's last refill, on (b)(6) 2018, in which there was a 3 ml discrepancy.The device was interrogated, on (b)(6) 2018, and a 3 ml reservoir volume discrepancy was noted.During the scheduled pump replacement surgery, on (b)(6) 2018, secondary to the worsening pain and pump reservoir volume discrepancy the healthcare provider (hcp) opened the pump pocket and clear fluid looking like csf, ¿poured¿ from the wound.The proximal catheter appeared to be kinked.The sutureless catheter connector was replaced and a new proximal segment attached to the new pump.The pump was then anchored.The side port was accessed and the implanter was unable to aspirate csf.Dye was injected and the entire catheter was under fluoroscopy.A leak was identified at the catheter anchor.The spinal segment was replaced.The clinical diagnosis was worsening pain and decreased therapeutic relief.It was indicated the event was related to the device or therapy.The issue resolved without sequelae on (b)(6) 2018.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider via a clinical study reported the patient's weight was 183 lbs.The cause of the catheter leak was not determined.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7518265
• MDR Text Key: 108390734
• Report Number: 3004209178-2018-11024
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2015
• 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: 06/04/2018
• Date Device Manufactured: 08/15/2013
• 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 Age: 39 YR
• Patient Weight: 83