PILLCAM
Received Nov 9, 2018 · Event occurred Oct 18, 2018
Report 8054825 · MDR key 8054825
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Imaging, Inc.Product problems
- Premature Discharge of Battery
- Defective Component
Patient
25550 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
GI FELLOW NOTIFIED ME OF CONCERNS HE HAD WITH THE CAPSULE ENDOSCOPY STUDIES. HE NOTICED THE CAPSULE ENDOSCOPY STUDY WAS VERY SHORT AND THEREFORE COULD NOT REPORT ANY FINDINGS BECAUSE THE STUDY WAS INCOMPLETE. ON FURTHER REVIEW OF THE STUDY, IT WAS DETERMINED THE STUDY ONLY RAN FOR 1:41 HOURS. A SECOND STUDY WAS THEN DONE ON THE PATIENT. THE SECOND STUDY RAN FOR 7:55:30 HOURS AFTER THE PATIENT SWALLOWED A 12 HOUR CAPSULE. THE 2 STUDIES WERE SENT IN TO MEDTRONIC PILLCAM TECH SUPPORT TO DETERMINE CAUSES OF SHORT STUDIES. 2 FINDINGS WERE REPORTED. "BAD SENSOR BELT AND SHORTENED BATTERY LIFE OF RECORDER BATTERY". UNABLE TO DETERMINE THE BAD SENSOR BELT OR SHORTENED BATTERY LIFE OF THE RECORDER PRIOR TO USE. DEVICES PULLED FROM PATIENT USE. MANUFACTURER RESPONSE FOR PILL CAM RECORDER AND BELT, (BRAND NOT PROVIDED) (PER SITE REPORTER). MEDTRONIC IS AWARE AND HAS INFORMED US ABOUT THE LIMITED BATTERY LIFE ALTHOUGH I DON'T THINK THEY HAVE A RESPONSE RELATED TO THE SENSOR BELT FAILURE.