inforMED
MalfunctionLHG

SYMMIX

Received Aug 28, 1998 · Event occurred May 1, 1997

Report 2182207-1997-00186 · MDR key 197932

Device

Generic name

Implantable Stimulation Lead

Manufacturer

Medtronic Inc.

Model number

3982

Catalog number

NA

Lot number

L33534

Product problems

  • Explanted

Patient

69 YR

  • Chest Pain
  • Undesired Nerve Stimulation
  • Pain
  • Surgical procedure

Narrative

Description of Event or Problem

PT BEGAN COMPLAINING OF SUDDEN ONSET OF SEVERE PAIN TO HER THORACIC AREA, ADJACENT TO THE SITE OF HER LAMINECTOMY. PT FELT SEVERE PAIN WHEN THE PHYSICIAN MERELY STROKED THE SKIN IN THE AREA. PHYSICIAN LIKENED THE PAIN TO THAT ASSOCIATED WITH SHINGLES. TURNING THE PULSE GENERATOR OFF MADE NO DIFFERENCE IN THE PT'S LEVEL OF PAIN, LEADING THE PHYSICIAN TO BELIEVE THAT THE ELECTRODE MAY BE TOUCHING ONE OF THE THORACIC NERVES. PHYSICIAN REMOVED THE PT'S ENTIRE STIMULATION SYSTEM, AND UPON EXPLANT, NOTED THAT THE WIRES IN THE LEAD LOOKED TWISTED. THE SYSTEM WAS RETURNED TO THE MFR FOR EVALUATION.