inforMED
InjuryGZJ

ULTIMA 5 T.E.N.S. UNIT

Received Feb 16, 2010 · Event occurred Feb 14, 2010

Report MW5014810 · MDR key 1610547

Device

Generic name

T.e.n.s. Unit

Lot number

CB12-0431

Product problems

  • Detachment Of Device Component

Patient

40 YR

  • Pain
  • Electric Shock

Narrative

Description of Event or Problem

THE DEPARTMENT OF (B) (6) GAVE ME A PAIN MANAGEMENT TECHNOLOGIES ULTIMA 5 T.E.N.S. UNIT TO HELP WITH MY CHRONIC BACK PAIN. GENERALLY IT WORKS WELL, BUT ON A NUMBER OF DAYS, THE LEADS FROM THE UNIT PULL FROM THE PADS - PLACED ON MY MID-BACK- AND DELIVER VERY PAINFUL ELECTRIC SHOCKS UNTIL I CAN TURN OFF THE DEVICE OR PULL THE LEADS OUT OF MY SHIRT. THE PADS ARE PLACED ON MY MID-BACK ON OPPOSITE SITES OF MY SPINE. THE LEADS GO DOWN TO MY PANTS AND ARE ROUTED AROUND MY SIDE TO THE T.E.N.S. DEVICE, WHICH IS ATTACHED TO MY BELT. THE LEADS WILL PULL AWAY AT VARIOUS TIMES, SOMETIMES JUST BECAUSE I HAVE SHIFTED MY SEATED POSITION. I THINK THE SOLUTION TO THIS PROBLEM IS TO ADD THE MALE CONNECTORS TO THE PAD LEADS, AND THE CABLE LEADS SHOULD BE FEMALE. THIS WILL PREVENT THE MALE LEADS TO TOUCH THE SKIN WHILE ENERGIZED SINCE THE PADS IMMEDIATELY LOSE POWER AS THEY ARE DISCONNECTED. I UNDERSTAND THAT THIS CHANGE WILL RAISE THE COSTS OF THE PADS, BUT I THINK THIS SOLUTION WILL MAKE THIS PRODUCT SAFER. FREQUENCY: AS NEEDED. DATES OF USE: (B) (6) 2009 -- (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: CHRONIC DEGENERATIVE DISK DISEASE.