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

Model Number 8637-40

Device Problem Material Integrity Problem (2978)

Patient Problems Dyspnea (1816); Headache (1880); Muscular Rigidity (1968); No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial #: (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 08-may-2011, 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 (hcp) via a company representative regarding a patient receiving baclofen (500 mcg/ml at 333 mcg/day) via an implanted pump.The indication for pump use was head/brain injury and intractable spasticity.It was reported that the patient went to the er (emergency room) on (b)(6) 2019 with a possible fractured catheter.The event date was noted to be ¿(b)(6) 2019¿.The pump and catheter were replaced on (b)(6) 2019.The catheter was fractured.No patient symptoms were reported.No further complications were reported/anticipated.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on (b)(6) 2019 from a healthcare professional (hcp) who reported that the patient¿s symptoms included a headache, shortness of breath, and increased leg spasticity.No further complications were reported/anticipated.

• 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: 8354615
• MDR Text Key: 136651652
• Report Number: 3004209178-2019-03608
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• 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: 02/27/2019
• Date Device Manufactured: 03/08/2013
• 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: 30 YR
• Patient Weight: 70