FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 3041745
·
Received April 8, 2013
Report
- Report Number
- 3007566237-2013-01157
- Event Type
- Injury
- Date Received
- April 8, 2013
- Report Date
- March 22, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS PREVIOUSLY REPORTED THE HEALTHCARE PROVIDER (HCP) WAS PLANNING TO OPEN THE IMPLANT SITE AND PUT ANTIBIOTIC MATERIAL IN THE DEVICE POCKET AND ¿STUFF IT.¿
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD DEVELOPED A HEMATOMA AND THEN GOT AN INFECTION AT THE DEVICE POCKET SITE. THE PATIENT WAS RECENTLY IMPLANTED. THE PATIENT'S HEALTH CARE PROVIDER (HCP) WAS GOING TO DO A PROCEDURE THE DAY OF REPORT TO ADDRESS THE INFECTION. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS PUT ON ANTIBIOTICS. THE PATIENT WAS DOING FINE AND NO OTHER TREATMENT WAS SCHEDULED AT THE TIME OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142825 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC NEUROMODULATION | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |