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

Model Number 8637-20

Device Problems Kinked (1339); Material Integrity Problem (2978)

Patient Problem Overdose (1988)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8711, serial# (b)(4), product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8711, serial/lot #: (b)(4), ubd: , udi#:.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving gablofen (2000 mcg/ml at 900 mcg/day) via an implantable infusion pump.It was reported that during a pump replacement surgery due to normal battery depletion, the catheter was found to be fractured.The caller stated that the healthcare provider (hcp) said that the catheter was kinked and he resolved it with a repair kit.It was reported that the medication was put at the pre-surgical rate, but that the patient was overdosed due to having had the catheter problem.No further complications have been reported as a result of this event.

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): 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: 7592021
• MDR Text Key: 110767568
• Report Number: 3004209178-2018-13201
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2018
• Date Device Manufactured: 02/18/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 20 YR