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

Model Number 8637-40

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id 8709, serial# (b)(4), implanted: (b)(6) 2012, 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 via a clinical study regarding a patient receiving dilaudid (750.0 mcg/ml at 250.03 mcg/day), bupivacaine (15.0 mg/ml at 5.001 mg/day) and clonidine (75.0 mcg/ml at 25.003 mcg/day) via an implanted pump.The indication for use was non-malignant pain and cervical radiculopathy.It was reported during a pump replacement, on (b)(6) 2017, secondary to normal battery depletion, a catheter occlusion was observer at the distal ports of the catheter tip.The occlusion was cleared with saline during pump replacement surgery.It was indicated the event was related to the device or therapy.The issue resolved without sequelae on (b)(6) 2017.

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 updated the drugs the patient was receiving at the time of the event to dilaudid (750.0 mcg/ml at 249.57 mcg/day), bupivacaine (15.0 mg/ml at 4.991 mg/day) and clonidine (75.0 mcg/ml at 24.957 mcg/day).

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 cause of the catheter occlusion was not determined and the patient's baseline weight was not measured.

• 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: 7175144
• MDR Text Key: 97667427
• Report Number: 3004209178-2018-00451
• Device Sequence Number: 1
• Product Code: LKK
• 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,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2013
• 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: 01/08/2018
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 01/17/2018; 01/31/2018
• Supplement Dates FDA Received: 01/18/2018; 02/01/2018
• Date Device Manufactured: 12/01/2011
• 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: 54 YR