MAUDE Adverse Event Report: RICE CREEK MFG SYNCHROMED EL; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8627L18

Device Problems Kinked (1339); Obstruction of Flow (2423)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/11/2005

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: product id: 8709, serial# (b)(4), implanted: (b)(6) 2017; product type: catheter.Product id: 8709, serial/lot #: (b)(4), ubd: 21-may-2003, udi#: (b)(4).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 baclofen at an unknown concentration and dosage via an implantable infusion pump.The indication for use was intractable spasticity.The patient had a medical history that included a spinal injury that left the patient bound to a wheelchair.It was reported that sometime in 2005, the patient experienced withdrawal due to the catheter getting kinked.The caller stated that the healthcare provider (hcp) performed a bolus which got rid of the kink.No further complications have been reported as a result of this event.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2001, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported by a healthcare provide via a business partner indicated that the patient had a medical history of spinal cord injury at t3-t4 with resultant bilateral lower extremity spasticity.It was reported that the patient had 5 ct scans to evaluate the catheter and spine and there was no clue what was wrong.No further complications have been reported.

• Brand Name: SYNCHROMED EL
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer (Section G): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7538183
• MDR Text Key: 109053284
• Report Number: 6000030-2018-00046
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2004
• Device Model Number: 8627L18
• Device Catalogue Number: 8627L18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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
• Patient Age: 24 YR
• Patient Weight: 68