inforMED
OtherLHG

RESUME

Received Jun 16, 2004

Report 2182207-2004-00792 · MDR key 530741

Device

Generic name

Lead

Manufacturer

Neuro

Model number

3986ILC

Catalog number

NA

Lot number

N26572

Product problems

  • Break
  • Device remains implanted

Patient

24 YR

  • Unknown (for use when the patient's condition is not known)
  • Surgical procedure

Narrative

Description of Event or Problem

MFR REP REPORTED LEAD WAS BROKEN PROXIMAL TO THE PADDLE PORTION. THE LEAD WAS CUT OFF, BUT THE PADDLE WAS LEFT IN PLACE AS A REFERENCE FOR PLACING A NEW LEAD. THE OTHER END OF THE EXTENSION WAS CUT OFF AT THE "BOOTIE." MFR REP STATED PORTION BETWEEN THE PADDLE AND THE BOOTIE WAS DISCARDED.