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
3982Catalog 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.