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

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); No Flow (2991)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Irritability (2421)

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): product id: 8709, serial# (b)(4), implanted: (b)(6) 2003, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 31-mar-2005, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On 2018-july-13, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving baclofen (2,000 mcg/ml, 400 mcg/day) via an implantable pump for intractable spasticity and cerebral palsy.Beginning on an unknown date, the patient experienced baclofen withdrawal and "increased spasticity irritability".There were no known environmental, external, or patient factors that may have led or contributed to the issue.The reported troubleshooting stated, "catheter access done with no flow observed".The catheter was replaced on (b)(6) 2018.The event was resolved at the time of this report.The patient's status was alive - no injury.

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): 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: 7690529
• MDR Text Key: 114070679
• Report Number: 3004209178-2018-15820
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• 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: 08/08/2018
• Date Device Manufactured: 06/16/2015
• 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): Other