FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 3943319
·
Received July 18, 2014
Report
- Report Number
- 3004209178-2014-13208
- Event Type
- Injury
- Date Received
- July 18, 2014
- Report Date
- June 27, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 4351-35, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 4351-35, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL 7-8 WEEKS AGO. THE PATIENT HAD A SYSTEMIC BLOOD INFECTION. THE DOCTOR DIAGNOSED THE PATIENT WITH (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423374 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00032 YR | Hospitalization |