FDA.reportPublic FDA data

MAUDE MDR 8054871

MDR report key
8054871
Report number
8054871
Event key
0
Event type
3
Date of event
2018-10-19
Date received
2018-11-09
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PILLCAMSYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULEGIVEN IMAGING INC.NSI41402X* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-090

Event Narratives#

D

Patient 1

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".