FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 3770080
·
Received April 24, 2014
Report
- Report Number
- 3004209178-2014-08045
- Event Type
- Injury
- Date Received
- April 24, 2014
- Report Date
- April 2, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 4351-35, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 4351-35, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR ABDOMINAL PAIN WHICH STARTED ABOUT A MONTH AGO. THE PATIENT FELT THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING. IT WAS NOTED THAT THEY WANTED A MANUFACTURER REPRESENTATIVE TO INTERROGATE THE INS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249344 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |