FDA Adverse Event Injury Summary report: N

BIONESS

MDR report key: 2023489 · Received March 14, 2011

Report

Report Number
MW5019817
Event Type
Injury
Date Received
March 14, 2011
Date of Event
January 21, 2011
Report Date
March 14, 2011
Manufacturer
BIONESS
Product Code
IPF
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
KS, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

BEGAN USE OF BIONESS H200 (B)(6) 2010, HAD SPASMS ON LEFT SIDE. KEPT USING PRODUCT 2 TIMES A WEEK THEN EVERYDAY (B)(6) 2010. OCCUPATIONAL THERAPIST AND BIONESS CLINICIAN DID NOT KNOW WHY I WAS HAVING SPASMS. THEY AFFECTED MY WALK, I BECAME UNSTEADY, BUT HAD NOT BEEN BEFORE USE OF H200. DECREASED TIME USING EXERCISE MODE OF DEVICE, BUT SPASMS CONTINUED TO GET WORSE. DISCHARGED FROM THERAPY, BIONESS CLINICIAN WENT ON MATERNITY LEAVE AND HER REPLACEMENT DID NOT RETURN CALLS I PLACED TO BIONESS, COMPLAINING OF PAIN. ADMITTED TO HOSPITAL (B)(6) 2011 FOR SPASMS ON LEFT SIDE OF BODY THAT AFFECTED MY BREATHING, CAUSED JERKING MOVEMENT IN MY LEFT ARM AND LEG, DIPLOPIA. BACLOFEN STARTED (B)(6) 2011. DISCHARGED (B)(6) 2011 ON 90 MG PER DAY OF BACLOFEN. ALSO USING 1 TO 1.5 MG ATIVAN EVERY 6 HOURS. ADMITTED TO HOSPITAL (B)(6) 2011 FOR SAME SPASMS ON LEFT SIDE OF BODY. DISCHARGED (B)(6) 2011. EMERGENCY VISIT FOR SAME SPASMS (B)(6) 2011. TREATED WITH 1 MG IV ATIVAN OR VALIUM AND 1 LITER IV FLUID. SENT HOME, SPASMS RESOLVED IN EMERGENCY DEPARTMENT. ADMITTED TO HOSPITAL (B)(6) 2011 FOR SPASMS, DID NOT RESOLVE, BREATHING AFFECTED. REMAIN IN HOSPITAL AT THIS TIME. STOPPED ATIVAN, STARTED VALIUM 5 MG AS WELL AS 90 MG OF BACLOFEN EVERY DAY. GETTING INTRATHECAL BACLOFEN PUMP (B)(6), DOSE STARTING AT 100 UMG/DAY. STOPPED USING BIONESS H200 (B)(6) 2011. STOPPED USING BIONESS L300 (B)(6) 2011. CA 125 ON (B)(6) 2009 <7. CA 125 93 ON (B)(6) 2010. CA 125 ON (B)(6) 2011 1000.CA 125 ON (B)(6) 2011 154, DID NOT USE BIONESS H200 4 WEEKS PRIOR TO THIS LAB. ALL CT'S OF CHEST/ABDOMEN/PELVIS - (B)(6) 2010, (B)(6) 2011 - NEGATIVE FOR CANCER. HAVE HX OVARIAN CANCER (B)(6) 2003.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BIONESS BIONESS H200 4.5 AMPS IPF BIONESS H200 UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 58 YR Hospitalization| S