ENTERRA
Report
- Report Number
- 3007566237-2013-00773
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HURTING REALLY BAD FROM THE BURNING/STINGING SENSATION AS REPORTED PREVIOUSLY. THE PATIENT STOPPED EATING BECAUSE HE COULD NOT EAT. THE PATIENT GOT NAUSEATED ALL THE TIME. THE PATIENT WOULD ¿THROW IT ALL UP TO THE POINT OF THROWING UP BLOOD.¿ IT WAS NOTED THAT THE PATIENT ONCE DROPPED 70 POUNDS IN THE COURSE OF FOUR MONTHS. IT WAS ALSO REPORTED THAT THE PATIENT FELT ¿SOMETHING¿S BEEN DISLODGED OR CAME APART.¿
IT WAS REPORTED THAT 3 WEEKS AGO THE PATIENT WAS SLEEPING, ROLLED OVER, FELT A POP AND THEN A BURNING/STINGING SENSATION STARTED IN THE PATIENT'S STOMACH WHICH LASTED ABOUT 4 HOURS. THE PATIENT FELT LIKE THE DEVICE SHORT CIRCUITED INSIDE OF HER; THE PATIENT FELT SHE WAS GETTING SHOCKED. THE PATIENT'S SYMPTOMS RETURNED 3 WEEKS AGO. PRIOR TO 3 WEEKS AGO THE DEVICE WAS WORKING GREAT. THE PATIENT HAD SOME ABDOMINAL PAIN BUT WAS ABLE TO EAT AND KEEP FOOD DOWN. THE PATIENT WANTED THE DOCTOR TO DO AN XRAY. THE DOCTOR WANTED TO TRY REPROGRAMMING. THE PATIENT WAS SCHEDULED TO BE SEEN IN FOLLOW UP BY THE HEALTH CARE PROFESSIONAL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105268 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC NEUROMODULATION | NEU_ENTERRA_INS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |