inforMED
InjuryJCY

CATHETER

Received Dec 27, 2011

Report 3007566237-2011-09352 · MDR key 2389667

Device

Generic name

Catheter, Infusion

Model number

NEU_UNKNOWN_CATH

Catalog number

NEU_UNKNOWN_CATH

Product problems

  • Insufficient Device Problem Information

Patient

00009 YR

  • Meningitis

Narrative

Description of Event or Problem

LITERATURE: BONOUVRIE, L. A., VAN SCHIE, P. E. M., BECHER, J. G., VAN OUWERKERK, W., J. R., REEUWIJK, A., VERMEULEN, R. J. EFFECTS OF INTRATHECAL BACLOFEN ON DAILY CARE IN CHILDREN WITH SECONDARY GENERALIZED DYSTONIA: A PILOT STUDY. EUROPEAN JOURNAL OF PAEDIATRIC NEUROLOGY 2011. 15: 539-543. DOI: 10.1016/J.EJPN.2011.05.003. SUMMARY: THE AUTHORS REPORT ON THE EFFECTS OF INTRATHECAL BACLOFEN (ITB) THERAPY ON PATIENTS WITH DYSTONIA. FOUR PATIENTS, THREE MALE AND ONE FEMALE, WERE EVALUATED BOTH DURING AN INITIAL ITB TRIAL WITH OPTIMAL DOSAGE AND A SUBSEQUENT DOUBLE-BLIND RANDOMIZED TRIAL INVOLVING ITB THERAPY AND INTRATHECAL PLACEBO. REPORTED EVENT: IN ONE (B)(6) MALE, ONE PREVIOUS TRIAL TREATMENT USING AN EXTERNAL CATHETER WAS COMPLICATED BY MENINGITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.