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

Model Number 8637-40

Device Problem Aspiration Issue (2883)

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

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

Product id: 8709, serial# (b)(4), implanted: (b)(6) 2005, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: (b)(6) 2007, udi#: (b)(4).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 device manufacturer representative regarding a patient receiving unknown medication at unknown concentration and dosage via an implantable infusion pump for the treatment of non-malignant pain and other non-malignant pain.It was reported that the patient experienced increased pain and felt like that they were going through withdrawal.There was no environmental/external/patient factors that may have led or contributed to the issue.Dye study was performed and there was no cerebrospinal fluid (csf) return.A catheter replacement was scheduled.The issue was not resolved and patient status was alive with no injury at the time of the report.No further complication was reported.

Manufacturer Narrative

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 device manufacturer representative regarding a patient receiving unknown medication at unknown concentration and dosage via an implantable infusion pump for the treatment of non-malignant pain and other non-malignant pain.It was reported that the patient experienced increased pain and felt like that they were going through withdrawal.There was no envi ronmental/external/patient factors that may have led or contributed to the issue.Dye study was performed and there was no cerebrospinal fluid (csf) return.A catheter replacement was scheduled on (b)(6)2018.The issue was not resolved and patient status was alive with no injury at the time of the report.No further complication was reported.

• 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: 7664134
• MDR Text Key: 113237955
• Report Number: 3004209178-2018-15061
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2018
• Date Device Manufactured: 08/04/2011
• 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: 63 YR