inforMED
InjuryLLK

ASCENDA

Received Jan 26, 2016 · Event occurred Dec 1, 2015

Report 3007566237-2016-00428 · MDR key 5390814

Device

Generic name

Legging, Compression, Non-inflatable

Model number

8782

Catalog number

8782

Product problems

  • Aspiration Issue

Patient

00016 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

CONCOMITANT PRODUCTS: PRODUCT ID: 8637-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem

INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING BACLOFEN (2000MCG/ML AT 450MCG/DAY) VIA AN IMPLANTED PUMP. INDICATION FOR USE WAS NOTED AS INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE HCP WAS GOING TO DO A DYE STUDY BUT COULD NOT ASPIRATE. THE HCP DECIDED TO REPLACE THE ENTIRE CATHETER ON (B)(6) 2015. IT WAS NOTED THAT THE PUMP HAD BEEN EMPTY SINCE (B)(6) 2015. NO SYMPTOMS WERE REPORTED. THE NEW DRUG WAS NOTED AS LIORESEAL (500MCG/ML AT 100MCG/DAY).