FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3071424
·
Received April 22, 2013
Report
- Report Number
- 3004209178-2013-06681
- Event Type
- Injury
- Date Received
- April 22, 2013
- Report Date
- March 26, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD A PUMP POCKET INCISION AND DRAINAGE (I AND D) AS WELL AS A SYSTEM EXPLANT, SECONDARY TO INFECTION. THERE WAS NO OTHER INFORMATION PROVIDED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION: A NEW PUMP AND CATHETER WERE BEING IMPLANTED ON THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173174 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |