FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 4170446
·
Received October 14, 2014
Report
- Report Number
- 3007566237-2014-02967
- Event Type
- Injury
- Date Received
- October 14, 2014
- Report Date
- February 24, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 4351, SERIAL # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 4351, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT WAS UNRELATED TO ¿FOREIGN BODY¿ AND HAD THE DEVICE REMOVED AT REQUEST OF INFECTIOUS DISEASE CONSULTANT. MEDICAL STATUS PRIOR TO EVENT, SYMPTOMS, CLINICAL COURSE, TREATMENT, AND OUTCOME WERE NOT GIVEN. ADDITIONAL INFORMATION IS BEING CONDUCTED TO OBTAIN THESE ANSWERS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651378 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC NEUROMODULATION | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |