FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1082985
·
Received July 28, 2008
Report
- Report Number
- 3004209178-2008-04441
- Event Type
- Injury
- Date Received
- July 28, 2008
- Date of Event
- June 27, 2008
- Report Date
- July 4, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE PT'S PARENTS NOTED SWELLING OVER THE INCISION ON THE PT'S BACK. THE PT WAS SEEN BY A HEALTH CARE PROFESSIONAL AND DIAGNOSED WITH AN INFECTION. THE PT WAS TREATED WITH UNSPECIFIED INTRAVENOUS ANTIBIOTICS. THE DEVICE SYSTEM WAS EXPLANTED. THE PT CONTINUED TO HAVE A FEVER. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL 8709SC LOT# N124273023| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED| EXPLANTED |