MEDTRONIC PILLCAM DR3 RECORDER
Received Nov 9, 2018 · Event occurred Oct 19, 2018
Report 8054823 · MDR key 8054823
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Imaging, Inc.Lot number
41402X
Product problems
- Premature Discharge of Battery
Patient
26645 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
GI LAB FELLOW NOTIFIED ME OF CONCERNS WITH THE CAPSULE ENDOSCOPY STUDIES. ON FURTHER EVALUATION I DETERMINED THE PATIENT SWALLOWED A 12 HOUR PILLCAM CAPSULE (5BS-SBB-5, LOT#41402X) FOR THE CAPSULE ENDOSCOPY. STUDY LENGTH AFTER DOWNLOAD WAS 8:30:13 HOURS, WHICH WAS A SHORTENED EXAM. STUDY SENT TO MEDTRONIC PILLCAM TECH SUPPORT TO DETERMINE WHY STUDY WAS SHORTENED. TECH SUPPORT REPORT SHOWS SHORT BATTERY LIFE ON RECORDER WITH 0% AT END OF STUDY. THERE WERE NO FACTORS PRESENT THAT WOULD HAVE IDENTIFIED A SHORTENED BATTERY LIFE ON THE RECORDER AT THE TIME PATIENT SWALLOWED CAPSULE. I LEARNED AFTER SPEAKING WITH MEDTRONIC REPRESENTATIVE THAT THE RECORDER TYPICALLY HAS A USE LIFE OF 2 YEARS AND 400 STUDIES. WE ARE AWARE THAT THE RECORDER WAS PURCHASED IN 2014. MANUFACTURER RESPONSE FOR MEDTRONIC PILLCAM DR3 RECORDER, (BRAND NOT PROVIDED), (PER SITE REPORTER). MEDTRONIC INFORMED US THE BATTERY WAS PROBABLY OLD, THIS IS INFORMATION THAT WOULD HAVE BEEN HELPFUL TO KNOW PRIOR TO PUTTING THE PATIENT THROUGH THE PROCEDURE.