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

Model Number 8637-20

Device Problems Aspiration Issue (2883); Infusion or Flow Problem (2964)

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

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 8709, serial# (b)(4), implanted: (b)(6) 2000, explanted: (b)(6) 2018, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 06-apr-2002, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a manufacturer's representative regarding a patient who was receiving 20 0mcg/ml compounded baclofen at 67mcg/day, 25mg/ml dilaudid at 7.5mg/day, and 275mcg/ml clonidine at 81mcg/day via an implantable infusion pump for chronic pain.It was reported that during a normal pump replacement due to battery life the doctor had difficulty asp irating the catheter.The catheter connector was replaced.It was reported the issue was resolved at the time of the report.The patient's status was noted as "alive-no injury." no further complications were anticipated/reported.

Manufacturer Narrative

Concomitant medical products: product id 8709, serial# (b)(4), implanted: (b)(6) 2000, explanted: (b)(6) 2018, product type catheter.The pump was returned, and analysis found corrosion and-or wear and-or lubrication and stall due to shaft-bearing.The catheter was returned and analysis found no significant anomalies.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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7655309
• MDR Text Key: 113002330
• Report Number: 3004209178-2018-14775
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Age: 81 YR