MAUDE Adverse Event Report: ACCUBOOST; BREAST BRACHY THERAPY

Device Problem Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Weakness (2145); Dysphasia (2195); Numbness (2415)

Event Date 08/31/2015

Event Type  Injury  

Event Description

Hospital admission (b)(6) 2015 discharged (b)(6) 2015.A (b)(6) female, noted to have numbness and generalized weakness in her right arm.Symptoms resolved within 10-15 minutes.Admitted to ed to be evaluated.Bp at this time 188/106.Pt recalls slurring of speech on the way to the hospital.Pt alert and oriented with normal motor function, no local deficits at time of admission.Consult completed by neurology.His impression symptom related to hypertension, but cannot exclude possibility of tia, so we will treat as tia.Grading of symptoms: hypertension - grade 2 unrelated to accuboost, tia - grade 3 unrelated to accuboost.Pt was treated with accuboost apbi on (b)(6) 2013 through (b)(6) 2013.Total dose 34 gy, 10 fractions.

• Brand Name: ACCUBOOST
• Type of Device: BREAST BRACHY THERAPY
• MDR Report Key: 5161589
• MDR Text Key: 28804943
• Report Number: MW5057163
• Device Sequence Number: 1
• Product Code: JAQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 88 YR
• Patient Weight: 56