FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 1171228
·
Received September 22, 2008
Report
- Report Number
- 3004209178-2008-05996
- Event Type
- Injury
- Date Received
- September 22, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 25, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WOULD START IN THE PATIENT'S STOMACH AND TRAVEL ALL THE WAY TO THE BACK OF HER HEAD. SHE WAS ADMITTED TO THE EMERGENCY ROOM IN [2008] AND WAS DISCHARGED TODAY [THREE DAYS LATER]. THE EVENT STARTED APPROX ONE WEEK AGO. SHE WAS GIVEN MEDICATION. SHE WAS AT HOME. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | LNQ | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| IMPLANTED| EXPLANTED| LEAD MODEL 4351 LOT# NHT007768N| IMPLANTED| LEAD MODEL 4351 LOT# NHT007769N |