SENSE SHOULDER COIL 1.5T 4CH

Additional Manufacturer Narrative

(B)(4). NO DEFINITE ROOT CAUSE FOR THE INJURY AS SUSTAINED BY THE PATIENT COULD BE DETERMINED. THE MOST LIKELY ROOT CASE IS A COMBINATION OF THE TECHNICIAN NOT USING ANY PATIENT VENTILATION IN COMBINATION WITH 8 CONSECUTIVE SCANS WITH HIGH SAR VALUES WITH-OUT PAUSES TO ALLOW FOR THE PATIENT BODY TO COOL DOWN.PRODUCT WAS NOT RETURNED TO THE MANUFACTURER, THE CUSTOMER HAS AN AGREEMENT WITH A THIRD PARTY SERVICE ORGANIZATION WHICH WAS UNABLE TO RETURN THE PRODUCT TO INVIVO.

Description of Event or Problem

A FEMALE PATIENT WAS POSITIONED HEAD FIRST SUPINE AND SCANNED WITH THE SHOULDER COIL FOR AN EXAMINATION OF THE LEFT SHOULDER. THE PATIENT STATED SHE FELT A TINGLING SENSATION AT THE TOP THE LEFT SHOULDER. AFTER THE EXAMINATION A SMALL BUMP WAS OBSERVED THAT DEVELOPED INTO A 4CM SIZE BLISTER ON TOP OF THE LEFT SHOULDER.

Additional Manufacturer Narrative

(B)(4). METHOD, RESULTS, CONCLUSIONS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.