FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 2133547
·
Received June 15, 2011
Report
- Report Number
- 3004209178-2011-04460
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 19, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LNQ
- PMA / PMN Number
- HDE99015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT'S APPETITE IMPROVED DURING HER IMPLANTABLE NEUROSTIMULATION TRIAL BUT SHE BEGAN TO GET FULL VERY QUICKLY. SHE HAD GOOD RELIEF FOR ABOUT 3 WEEKS BUT THEN HER SYMPTOMS RETURNED. A LEAD REVISION WAS PERFORMED BUT THE PATIENT STILL WAS NOT RECEIVING A THERAPEUTIC BENEFIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | LNQ | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Required Intervention | EXPLANTED:| LEAD: MODEL 4351, LOT# NHT013821N| LEAD: MODEL 4351, LOT# NHT013822N| EXPLANTED:| IMPLANTED:| IMPLANTED: |