inforMED
MalfunctionLTB

KENTROX SL 65/16

Received Aug 11, 2006 · Event occurred Jul 11, 2006

Report 1028232-2006-00163 · MDR key 771472

Device

Generic name

Icd Lead

Model number

342397

Catalog number

342397

Lot number

*

Product problems

  • Device remains implanted
  • Replace
  • Inappropriate/Inadequate Shock/Stimulation

Patient

53 YR

  • Hospitalization required

Narrative

Description of Event or Problem

FROM DEVICE AND MDR. INAPPROPRIATE SHOCKS AND NOISE ON IEGM FOUND TO BE CAUSED BY THE PACE/SENSE PORTION OF THE ICD LEAD. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND A NEW PACE/SENSE LEAD WAS IMPLANTED.