FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1892196
·
Received November 2, 2010
Report
- Report Number
- 3004209178-2010-08772
- Event Type
- Injury
- Date Received
- November 2, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 10, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED 10 DAYS AFTER THE PUMP WAS IMPLANTED THAT THE PT EXPERIENCED AN INFECTION. THE PUMP WAS EXPLANTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, 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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention | EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNKNOWN| IMPLANTED: |