inforMED
InjuryLPQ

EXOGEN 4000

Received Feb 24, 2012 · Event occurred Jan 26, 2012

Report 1020279-2012-00107 · MDR key 2466810

Device

Generic name

Bone Growth Stimulator

Model number

OR71034100

Catalog number

71034100

Lot number

11LM02401

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Chest Pain
  • Nonunion/Delayed-union Bone Fracture

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN THAT RESOLVED WITH TREATMENT WITH SUBLINGUAL NTG ABOUT 4 HOURS FOLLOWING THE USE OF EXOGEN. SHE DID NOT SEEK EMERGENCY MEDICAL CARE FOR THE CHEST PAIN. SHE REPORTED THE EPISODE THE FOLLOWING MORNING TO HER CARDIOLOGIST , CONCERNED THAT THE CHEST PAIN WAS A RESULT OF AN INTERACTION BETWEEN EXOGEN AND HER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. HE ADVISED HER TO DISCONTINUE EXOGEN. THE PATIENT HAD USED EXOGEN TWICE BEFORE WITHOUT PROBLEM, HOWEVER, SHE EXPERIENCED THE CHEST PAIN WITH HER THIRD TREATMENT. SHE WAS PRESCRIBED EXOGEN FOR THE NONUNION OF A PROXIMAL LEFT HUMERUS FRACTURE. SHE HAS A HISTORY OF CARDIOVASCULAR DISEASE AND IS S/P CORONARY ARTERY BY-PASS GRAFT SURGERY. BECAUSE OF CONCERNS ABOUT A POTENTIAL INTERACTION, THE PATIENT WAS SUBSEQUENTLY REFERRED BACK TO THE CARDIOLOGIST FOR A PRE-OP EVALUATION ON (B)(6) 2012 FOR SURGICAL TREATMENT OF THE NONUNION.