FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1040275
·
Received May 8, 2008
Report
- Report Number
- 3004209178-2008-02491
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- February 23, 2008
- Report Date
- April 9, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO AN INFECTION. NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; THE MFR'S DEVICE REGISTRATION SYS INDICATES IT IS LIORESAL. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention | PROGRAMMER MODEL 8840 LOT#UNK| EXPLANTED| IMPLANTED| CATHETER MODEL 8709 LOT# N106808010 |