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

Model Number 8637-40

Device Problem Occlusion Within Device (1423)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 8709, serial# (b)(4), implanted: (b)(6) 2011, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient receiving compounded baclofen (200.0 mcg/ml at 100.27 mcg/day), hydromorphone (42.0 mcg/ml at 21.057 mcg/day), and prialt (10.0 mcg/ml at 5.013 mcg/day) via an implantable infusion pump.The indication for use was noted as spinal pain.It was reported the patient reported increased pain and a lack of therapeutic relief with personal therapy manager (ptm) activations on (b)(6) 2017.The device was reprogrammed on (b)(6) 2017 where the intrathecal continuous rate, the bolus dose, and the maximum number of activations were increased.On (b)(6) 2018 a catheter access port (cap) contrast dye study revealed minor 'clogging' at the catheter tip.The catheter was flushed with saline and adequate flow was obtained.The event resulted in an unscheduled clinic or office visit.The outcome was resolved without sequelae on 2018-jan-03.The device diagnosis was catheter occlusion.The clinical diagnosis was decreased therapeutic relief.The cause of the catheter occlusion was not determined.The etiology was noted as related to the device or therapy and not related to the implant procedure.No further complications were anticipated/reported.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7248825
• MDR Text Key: 99801675
• Report Number: 3004209178-2018-02263
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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
• Report Date: 02/07/2018

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: 01/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/07/2018
• Date Device Manufactured: 08/11/2017
• 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 Age: 78 YR
• Patient Weight: 109