FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2143031
·
Received June 23, 2011
Report
- Report Number
- 3004209178-2011-04724
- Event Type
- Injury
- Date Received
- June 23, 2011
- Report Date
- May 27, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
THE PT EXPERIENCED AN INFECTION, FURTHER DETAILS WERE NOT REPORTED. THE PUMP WAS REMOVED. THE PT STATUS AFTER THE DEVICE WAS REMOVED, WAS REPORTED AS RECOVERED WITHOUT SEQUELA. A F/U 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 | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N226174007| IMPLANTED: |