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

Model Number 8637-20

Device Problems Difficult to Insert (1316); Migration or Expulsion of Device (1395); Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problem Arachnoiditis, Spinal (2390)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type: catheter.Product id: 8780, serial# (b)(4), product type: catheter.

Event Description

Information was received from a healthcare professional via a company representative regarding a patient receiving fentanyl (4,000 mcg/ml at 192.1 mcg/day) and clonidine (200 mcg/ml at 9.61 mcg/day) via an implanted pump.The indication for pump use was non-malignant pain.On (b)(6) 2016 the patient had a catheter dye study and the radiologist was unable to aspirate.The patient¿s managing physician had been treating the patient with oral medication.The patient had not had withdrawal symptoms.On (b)(6) 2017 the patient was taken to surgery and in surgery the surgeon attempted to aspirate the catheter and he was unable to.He felt that the catheter may be out of the intrathecal space, so he attempted to insert a new catheter but was unable to.The surgeon felt that maybe the patient had arachnoiditis, but also there was so much bone he had trouble getting into the intrathecal space.The surgeon chose not to proceed.The existing pump and catheter were removed.The issue was resolved.The patient status was reported as ¿alive ¿ no injury¿.It was unknown if any environmental, external, or patient factors led or contributed to the inability to aspirate.

Manufacturer Narrative

Device code (b)(4) is no longer applicable for this event.

Event Description

Additional information was received and it was reported that the difficulty encountered during the surgery when trying to implant the new catheter was that the surgeon could not get the needle into an open space; it wasn¿t an issue with the catheter.

Manufacturer Narrative

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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6303854
• MDR Text Key: 66599229
• Report Number: 3004209178-2017-02609
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• 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: 02/07/2017
• Date Device Manufactured: 02/03/2014
• 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: 68 YR