MAUDE MDR 2466810

MDR report key: 2466810
Report number: 1020279-2012-00107
Event key: 0
Event type: 3
Date of event: 2012-01-26
Date received: 2012-02-24
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 305
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: MRS. CONNIE MCBROOM
Address: 1450 E. BROOKS ROAD MEMPHIS TN 38116 US
Phone: 901-901-9013
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	EXOGEN 4000	BONE GROWTH STIMULATOR	SMITH & NEPHEW ORTHOPAEDICS	LPQ	OR71034100	71034100	11LM02401				*	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2012-02-24	0	1. R

Event Narratives#

D

Patient 1

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.

N