inforMED
MalfunctionPCB

MEDTRONIC EDM LUMBAR DRAINAGE KIT W/120ML GRADUATED

Received Nov 19, 2018 · Event occurred Oct 30, 2018

Report MW5081456 · MDR key 8089475

Device

Generic name

External Cerebrospinal Fluid Diversion

Model number

EDM

Lot number

210491239

Product problems

  • Break
  • Detachment of Device or Device Component
  • Output Problem

Patient

70 YR

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

Narrative

Description of Event or Problem

LUMBER DRAIN PLACED WITHOUT OUTPUT IN THE FIRST HOUR; FOUND A PORTION OF THE DRAIN BROKE OFF IN PATIENT; REMOVED.