FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 1002481
·
Received February 25, 2008
Report
- Report Number
- 3004209178-2008-00853
- Event Type
- Injury
- Date Received
- February 25, 2008
- Date of Event
- January 4, 2008
- Report Date
- January 24, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- HDE99015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. IF FURTHER INFORMATION IS RECEIVED OR THE DEVICE RETURNED, A FOLLOW-UP MEDWATCH REPORT WILL BE SENT.
Description of Event or Problem · 1
THE MANUFACTURER'S REPRESENTATIVE REPORTED THAT THE PATIENT'S ENTERRA DEVICE WAS REMOVED DUE TO INFECTION. THE PATIENT EXPERIENCED PAIN AND WARMTH OVER THE DEVICE. ANTIBIOTICS WERE ADMINISTERED AND THE INFECTION IMPROVED, BUT THE PATIENT ELECTED TO HAVE IT EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other | LEAD MODEL 4351| EXPLANTED |