FDA.reportPublic FDA data

MAUDE MDR 9611369

MDR report key
9611369
Report number
3008766073-2020-00017
Event key
0
Event type
3
Date of event
2019-12-27
Date received
2020-01-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
4188 LEXINGTON AVENUE NORTH SHOREVIEW MN
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
11.5T LINX, 15BANTI-REFLUX IMPLANTTORAX MEDICAL, INC.LEILXMC16LXMC15R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-210

Event Narratives#

N

Patient 1

(B)(4). DATE SENT: 1/21/2020. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT WAS THE DATE OF IMPLANT? WHAT IS THE LOT NUMBER FOR THE LXMC16 LINX DEVICE? WERE THERE ANY OTHER CONTRIBUTING FACTORS THAT LED TO THE REMOVAL OF THE DEVICE OTHER THAN THE PATIENT?S ANXIETY? DOES THE SURGEON BELIEVE THAT THERE WAS AN ALLEGED DEFICIENCY WITH THE LINX DEVICE? IF YES, PLEASE EXPLAIN. IS THE PATIENT DOING WELL SINCE REMOVAL?

D

Patient 1

IT WAS REPORTED THAT THE LINX DEVICE WAS EXPLANTED ON (B)(6) 2019 DUE TO PATIENT ANXIETY AROUND HAVING THE IMPLANT. IT WAS ORIGINALLY IMPLANTED DUE TO GERD. THERE WERE NO PATIENT CONSEQUENCES.