FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 1181192
·
Received September 30, 2008
Report
- Report Number
- 3004209178-2008-06221
- Event Type
- Injury
- Date Received
- September 30, 2008
- Date of Event
- August 25, 2008
- Report Date
- September 4, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WENT TO THE EMERGENCY ROOM BECAUSE SHE HAD A FEVER AND AN "EXPOSED LEAD WIRE" THROUGH HER HEAD THAT WAS OOZING. SHE WAS TRANSPORTED TO ANOTHER FACILITY AND SEEN BY A NEUROSURGEON. THE ENTIRE IMPLANTED SYSTEM WAS REMOVED. THE PATIENT WAS ON UNSPECIFIED INTRAVENOUS ANTIBIOTICS AS WELL AS ORAL AND HAD A FOLLOW-UP APPOINTMENT SCHEDULED. THE INFECTIOUS DISEASE REPORT SAID, THE INFECTION WAS DUE TO PSEUDOMONAS AERUGINOSA. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD MODEL 3387S| PRGORAMMER MODEL 7436| EXPLANTED| EXPLANTED| EXTENSION MODEL 7482A |