FDA Adverse Event Malfunction Summary report: N

ENTERRA II IPG

MDR report key: 18923938 · Received March 18, 2024

Report

Report Number
3027386225-2024-00021
Event Type
Malfunction
Date Received
March 18, 2024
Date of Event
February 19, 2024
Report Date
February 27, 2024
Manufacturer
ENTERRA MEDICAL, INC
Product Code
LNQ
UDI-DI
00763000449704
PMA / PMN Number
H990014
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

CUSTOMER SERVICE RECEIVED A PHONE CALL ON THE MAIN LINE FROM THE PATIENT'S MOTHER ABOUT HER DAUGHTER. HER DAUGHTER HAS AN ENTERRA II. SHE SAID SHE CALLED A FEW MONTHS AGO AND TALKED WITH HER LOCAL SALES REP WAS REFERRED TO SOMEONE IN HER AREA FOR HER DAUGHTERS DEVICE. HER DAUGHTERS SHOCKING IS GETTING WORSE AND THE SHOCKING IS GOING INTO HER FACE. THIS CALL WAS TRANSFERRED TO (B)(6) AT TECH SUPPORT FOR FURTHER ASSISTANCE. PATIENT'S MOTHER IS STATING EXPERIENCING WORSENING SHOCKING IN THE STOMACH THAT HAS WORKED THE WAY UP TO THE PATIENTS FACE. PATIENT IS REPORTEDLY EXPERIENCING A SHOCKING SENSATION THAT THEY DID NOT HAPPEN WITH THEIR ORIGINAL ENTERRA DEVICE, FOLLOWING A BATTERY CHANGE BY DR. (B)(6). THEY CLAIM TO BE EXPERIENCING A SHOCKING IN THE ABDOMEN, BACK, AND RADIATING UP TO THEIR NECK AND FACE. ENTERRA MEDICAL INC. RECOMMENDED TO GO BACK TO THEIR MANAGING PROVIDER TO INVESTIGATE SHOCKING SENSATION ((B)(6), DR (B)(6)). THEY WANTED ADDITIONAL IMPLANTING CENTERS TO MEET WITH ANOTHER GI FOR A SECOND OPINION. NEXT CLOSEST OPTIONS WERE (B)(6). ENTERRA PROVIDED NAMES AND CONTACT INFO FOR THREE OPTIONS IN THOSE CITIES FROM THE PHYSICIAN FINDER. AS OF (B)(6) 2024, THEY HAVE YET TO MAKE AN APPOINTMENT OR BE SEEN BY A PHYSICIAN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
181192 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC 37800 00763000449704

Patients

Seq Age Sex Outcome Treatment
1 40 YR Female Other