FDA Adverse Event Injury Summary report: N

INTEGRAL LUMBAR DRAINAGE SETS (ILDS).

MDR report key: 319631 · Received March 12, 2001

Report

Report Number
9612007-2001-00013
Event Type
Injury
Date Received
March 12, 2001
Date of Event
January 16, 2001
Report Date
February 22, 2001
Manufacturer
NMT NEUROSCIENCES IMPLANTS SA
Product Code
JXG
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IT
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

BREAKAGE OF THE LUMBAR CATHETER, WHEN TRYING TO REPOSITION IT. THE PT NEEDS A 2ND SURGICAL INTERVENTION TO RETRIEVE THE CATHETER PIECE. THIS COMPLAINT HAS BEEN REPORTED TO THE MINISTRY OF HEALTH BY THE HOSP. THE INVOLVED CATHETER WAS NOT RETURNED TO NMT. NO COMPLICATIONS WERE REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
10964 INTEGRAL LUMBAR DRAINAGE SETS (ILDS). EXTERNAL DRAINAGE SETS. JXG NMT NEUROSCIENCES IMPLANTS SA NA 106325 OR 106141 OR 106024

Patients

Seq Age Sex Outcome Treatment
1 56 YR Required Intervention