inforMED
InjuryPCC

CEFALY DUAL

Received Oct 9, 2019 · Event occurred Aug 30, 2019

Report MW5090320 · MDR key 9174633

Device

Generic name

Stimulator, Nerve, Electrical, Transcutaneous For Migraine

Manufacturer

Cefaly Technology

Model number

CEFALY DUAL

Product problems

  • Patient-Device Incompatibility

Patient

60 YR

  • Vitreous Floaters
  • Headache
  • Pain
  • Blurred Vision
  • Visual Impairment
  • Visual Disturbances
  • Halo
  • Vitreous Floaters
  • Headache
  • Pain
  • Blurred Vision
  • Visual Impairment
  • Visual Disturbances
  • Halo

Narrative

Description of Event or Problem

LOCAL TITLE: IC/OPHTHALMOLOGY (D), STANDARD TITLE: OPHTHALMOLOGY NOTE, DATE OF NOTE: (B)(6), 2019 AT 15:18, ENTRY DATE: (B)(6) 2019 AT 15:81:20, AUTHOR: (B)(6) EXP COSIGNER, URGENCY, STATUS: COMPLETED. EYE CLINIC PERSONNEL FOLLOWED THE FACILITY APPROVED EYE DROP ALGORITHM PRIOR TO THE PHYSICIAN EXAMINING THE PT. PRIMARY CARE PROVIDER: ALAM, MITIL. ALLERGIES: CODEINE ((B)(6) 2002), TRAMADOL, ((B)(6) 2017), ATORVASTATIN ((B)(6) 2018), GLASSES ELIGIBLE: SERVICE CONNECTION: SERVICE CONNECTED %-90. OTHER REASON FOR ELIGIBILITY: THIS IS A (B)(6) Y/O MALE WHO IS HERE FOR EVALUATION OF VISION CHANGES-SPOTS/SHADOWS. PLEASE SEE ENT TELEPHONE NOTE DATED SEPTEMBER 05, 2019 FOR ADD'L INFO. VISION CHANGES BEGAN FRIDAY, ALONG WITH SHADOWS AND VEIL OU, WORSE ON THE RIGHT. STILL HAS HA, FEELS LIKE MIGRAINE BUT NOT A BAD MIGRAINE. STATES FLASHING CD IS DIFFERENT THAN WHEN HE GETS MIGRAINES. FLASHING BEGAN AS A HALF CIRCLE UPPER, NOW IT'S LOWER. STATES HE IS NOT FEELING THE BEST RIGHT NOW. STATES HA PAIN (B)(6) TODAY HPI/BJJ: PT HERE FOR ADD ON OF NEW FLASHES / FLOATERS. MOST OF HIS SYMPTOMS ARE IN THE RIGHT EYE. HE SEES BRIGHT FLASHES THAT ARE AN ARC OF LIGHT, EVEN IN THE DARK. HE ALSO SEES A BIG ROUND FLOATER IN THE CENTER OF HIS VISION THAT DRIFTS AROUND BUT HE CAN'T ALWAYS GET RID OF IT. IN THE LEFT EYE HE SEES SOME STRANDS, BUT NOT AS PROMINENT AS THE RIGHT EYE. THE VISION SEEMS SLIGHTLY BLURRED SINCE THIS ALL BEGAN. HE WAS USING A ACEPHALY DEVICE FOR MIGRAINES BEFORE THIS ALL OCCURRED. PER THE ENT NOTE, "RECEIVED PHONE CALL FROM PT HE HAS HAD A HEADACHE AND SEEING SPOTS / SHADOWS SINCE (B)(6) USED CEFALY DEVICE FOR MIGRAINES. PT REPORTS SUDDEN ONSET, CONSTANT, SEEING FLASHES AND FLOATERS ANYTIME HE CHANGES HIS POINT OF VISION. WHEN CLOSING R EYE HE SEES FULL TV/SCREEN. WHEN CLOSING L EYE HE SEES A SPOT THAT IS OFF TO RIGHT A QUARTER OF AN INCH FROM THE CENTER OF VISION. PT REPORTS DISTORTED VISION, FAKING AND HALOS, DENIES DIPLOPIA. PT DENIES EYE PAIN, DENIES N/V. PT REPORTS HEADACHE, DENIES FACIAL AND JAW PAIN. PT DENIES RED OR MATTER EYES. PT DENIES ANY TRAUMA, BURN OR INJURY. PT REPORTS HE IS WEARING GLASSES AND HAS NOT USED HIS CONTACTS SINCE (B)(6). (B)(6) RECOMMENDS PT BE SEEN IN CLINIC TODAY OR TOMORROW. OFFERED PT APPT TODAY AT 1300." PAST OCULAR HISTORY: REFRACTIVE ERROR, NO HISTORY OF OCULAR TRAUMA; PAST OCULAR SURGERY: NONE OCULAR MEDICATIONS, NONE OCULAR FAMILY HISTORY, NO KNOWN FAMILY HISTORY OF EYE PROBLEMS; PMH: DM, HTN, HLD, MIGRAINES, COPD, IMPRESSION/PLAN, ACUTE SYMPTOMATIC POSTERIOR VITREOUS DETACHMENT (PVD) RIGHT EYE. THE PT IS PRESENTING WITH THE TYPICAL SYMPTOMS OF PHOTOPSIA ND FLOATERS AND ON EXAMINATION THERE IS A PVD. ON 360 DEGREE SCLERAL DEPRESSED EXAM, NO RETINAL BREAKS OR DETACHMENTS WERE NOTED. DISCUSSED THE RISK OF RETINAL TEARS (10% OF PVD). THE SYMPTOMS OF RETINAL DETACHMENT HAVE BEEN REVIEWED WITH THE PT INCLUDING FLASHES, INCREASED FLOATERS, OR CURTAIN/VEIL OVER VISION. THEY EXPRESSED AGREEMENT AND UNDERSTAND TO CALL / RETURN TO OPHTHALMOLOGY URGENTLY FOR ANY NEW OR WORSENING SYMPTOMS. RETURN FOR REPEAT DILATED EXAM WITH SCLERAL DEPRESSION IN 4 WEEKS. DIABETES WITHOUT DIABETIC RETINOPATHY. ENCOURAGE TIGHT GLUCOSE AND BLOOD PRESSURE CONTROL, AND DISCUSSED IMPORTANCE WITH PT. WILL CONTINUE TO MONITOR FOR PROGRESSION FOR RETINOPATHY WITH DILATED EXAM. LAST A1C 7.8 #CATARACT OU, NVS, OBSERVE RTC 4 WEEKS, REPEAT SDE OU. FDA SAFETY REPORT ID# (B)(4).