FDA.reportPublic FDA data

MAUDE MDR 9574381

MDR report key
9574381
Report number
3008766073-2020-00008
Event key
0
Event type
3
Date of event
2019-12-15
Date received
2020-01-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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, 14BANTI-REFLUX IMPLANTTORAX MEDICAL, INC.LEILXMC14LXMC14Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-100

Event Narratives#

N

Patient 1

(B)(4). DATE OF EVENT: EXPLANT APPROX. (B)(6) 2019 OR (B)(6) 2019. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PRIOR TO LINX PLACEMENT, DID THE PATIENT HAVE AN EGD, PH, AND MANOMETRY STUDIES DONE (IF YES, COULD YOU PLEASE SHARE THE RESULTS?) - YES. ON WHAT DATE DID THE IMPLANT TAKE PLACE? 6 WEEKS BEFORE EXPLANT. ON WHAT DATE DID THE EXPLANT TAKE PLACE? 1-2 DAYS BEFORE I SUBMITTED PC. WHAT IS THE LOT NUMBER OF THE LINX DEVICE? WHEN USING THE LINX SIZING DEVICE WHAT TECHNIQUE WAS USED TO DETERMINE THE SIZE? 3 POP. DID THE PATIENT HAVE AN AUTOIMMUNE DISEASE? IS THE PATIENT CURRENTLY TAKING STEROIDS / IMMUNIZATION DRUGS? DID THE PATIENT HAVE ANY PRE-EXISTING DYSPHAGIA OR OTHER CONDITIONS (OTHER THAN GERD)? HOW SEVERE WAS THE DYSPHAGIA/ODYNOPHAGIA BEFORE INTERVENTION? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT? NO. WAS THERE ANY HIATAL OR CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? YES. WERE THERE ANY OTHER CONTRIBUTING FACTORS THAT LED TO THE REMOVAL OF THE DEVICE OTHER THAN THE REPORTED DYSPHAGIA? NO. WAS THE DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL? YES.

D

Patient 1

IT WAS REPORTED THAT THE LINX DEVICE WAS EXPLANTED. HE SAID THAT THE PATIENT HAD THE LINX DEVICE IMPLANTED APPROXIMATELY 6 WEEKS AGO. THE PATIENT HAD TERRIBLE DYSPHAGIA, SO IT WAS EXPLANTED. HE SAID THAT THE DEVICE WAS SCARRED IN SIGNIFICANTLY. EXPLANT WENT FINE. NO PATIENT CONSEQUENCES. HE DID NOT DO ANOTHER REFLUX PROCEDURE.