MalfunctionNSI

PILLCAM

Received Nov 9, 2018 · Event occurred Oct 19, 2018

Report 8054871 · MDR key 8054871

Device

Generic name

System, Imaging, Esophageal, Wireless, Capsule

Manufacturer

Given Imaging Inc.

Lot number

41402X

Product problems

Defective Component

Patient

27010 DA

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PATIENT SWALLOWED A 12-HOUR PILLCAM CAPSULE (MHV-HUC-7, LOT#41402X) FOR A CAPSULE ENDOSCOPY. STUDY LENGTH AFTER DOWNLOAD WAS 1:54:06 HOURS WHICH WAS A VERY SHORTENED EXAM AND GAPS NOTICED. STUDY SENT TO MEDTRONIC PILLCAM TECH SUPPORT TO DETERMINE WHY STUDY WAS SHORTENED. TECH SUPPORT REPORT SHOWS A "BAD SENSOR BELT".