REM PAD
Received Mar 10, 2026
Report MW5185036 · MDR key 24567331
Device
Generic name
Electrosurgical, Cutting & Coagulation & Accessories
Manufacturer
Medline Industries, Lp (northpoint Services)Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DESCRIPTION OF EVENT: IT WAS REPORTED THAT DURING AN OPEN PROCEDURE OF T10-PELVIS POSTERIOR INSTRUMENTED REVISION/ EXTENSION OF PRIOR FUSION WITH POSTERIOR COLUMN OSTEOTOMIES, L2-3 LAMINECTOMY/ EXPLANT OF HARDWARE, T9+10 VERTEBROPLASTY, T9-11 LIGAMENT AUGMENTATION IN SURGERY ROOM SEVEN, DURING DISSECTION WITH THE REM (RETURN ELECTRODE MONITORING) PAD PLACED ON THE UPPER THIGH, THE VLFT10GEN HAD AN ISSUE WHEN USING THE MONOPOLAR PENCIL, THE PATIENT STARTED TO BRADY DOWN (EXPERIENCE BRADYCARDIA), PRIOR TO RESUMING NORMAL CARDIAC RHYTHM. THE SURGICAL TIME WAS EXTENDED BY FIVE MINUTES. TWO NON-(B)(6) PEN, TWO NON-(B)(6) REM PADS, AND TWO ESU (ELECTROSURGICAL UNIT) UNITS WERE USED. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)". PT CODE: 4582. DEVICE CODE: 2993. REF REPORT: MW5185035.